FDA-ECG
•
0 likes•167 views
星
星宇 杨This document is an entry from the FDA's 510(k) Premarket Notification Database providing information about a disposable electrocardiograph electrode. It lists the 510(k) number, regulation number, applicant name, product code, dates the notification was received and reviewed, review outcome of substantially equivalent, and that it received a traditional review without third party or expedited review.
Report
Share
Report
Share
Download to read offline
Recommended
BAX Introduction Report
Baxter International is a medical supplies company headquartered in Deerfield, Illinois that was founded in 1931. It has major accomplishments in blood storage in the 1930s, dialysis in the 1940s, and blood oxygenators and cell separators in later decades. Baxter operates in two business segments, BioScience and Medical Products, with BioScience focusing on treatments for blood disorders, immune deficiencies, burns and shock. Baxter has sales in over 100 countries worldwide, with international sales making up around 58% of its business in recent years.
CLINICAL RESEARCH CASE STUDY
This document discusses issues with a clinical trial for the drug Ketek submitted to multiple IRBs. It summarizes that the GAO submitted the Ketek protocol to 3 different IRBs, two of which rejected it but one approved it. However, Ketek was withdrawn from the market in 2007 due to serious adverse events including deaths and infections. The FDA later inspected the study and issued a warning letter to the approving IRB, questioning the trial. Lessons for IRB members are to prioritize patient safety, scrutinize sponsor and protocol details, and maintain documents for at least two years.
Inf10 charlotte gastro_infographic
See how one GI practice in North Carolina achieved over half-million dollars a year in savings and other benefits after adopting NextGen Ambulatory EHR and Practice Management.
Aethlon receives government contract
Aethlon Medical news disclosure of government contract award to develop medical device to prevent sepsis in combat-injured soldiers.
Saor Commercialisation V2
The document discusses semantic interoperability in healthcare and SAOR's solution. It describes the current fragmented state of hospital information systems and vision for improved integration. SAOR offers a semantic mediation platform that can integrate different clinical systems like EPRs more robustly and flexibly than current HL7 engine approaches through use of ontologies. Plans are outlined to develop prototypes, conduct validation trials, and license the technology to software vendors and health services.
Plug and Play Electronic Patient Records
PPEPR software aims to enable plug-and-play electronic patient records by developing an intelligent automation system using semantics. It offers a solution to integrate different clinical systems like radiology and oncology more efficiently by validating, routing, and transforming message between systems. The current plans are to develop prototypes in 2006-2007 and conduct validation trials in 2008 while engaging clinical partners and seeking advisory board input.
ECOG-ACRIN Roster Update Form
This document provides instructions for updating a roster for the ECOG-ACRIN Cancer Research Group. It outlines the steps for research personnel to obtain a CTEP identification number and complete a roster update form to be added to the ECOG-ACRIN database. Physicians obtain a CTEP Investigator ID and non-physicians a CTEP Associate ID. The form requests name, contact, and institutional affiliation information as well as specialty, degrees, and CTEP ID for listing. It also provides options to serve as a registrar and instructions to submit completed forms by email or fax.
Judith Ngere_App Note Abstract
The document describes a study using the Agilent 6230 TOF mass spectrometer to screen for 15 drugs listed in the UK Drug Driving Law in blood samples. An all-ions MS/MS method was developed that utilized in-source fragmentation and an accurate mass MS/MS library to identify compounds through fragment matching down to a limit of detection of 2ng/mL, meeting or exceeding the threshold limits in the law.
Recommended
BAX Introduction Report
Baxter International is a medical supplies company headquartered in Deerfield, Illinois that was founded in 1931. It has major accomplishments in blood storage in the 1930s, dialysis in the 1940s, and blood oxygenators and cell separators in later decades. Baxter operates in two business segments, BioScience and Medical Products, with BioScience focusing on treatments for blood disorders, immune deficiencies, burns and shock. Baxter has sales in over 100 countries worldwide, with international sales making up around 58% of its business in recent years.
CLINICAL RESEARCH CASE STUDY
This document discusses issues with a clinical trial for the drug Ketek submitted to multiple IRBs. It summarizes that the GAO submitted the Ketek protocol to 3 different IRBs, two of which rejected it but one approved it. However, Ketek was withdrawn from the market in 2007 due to serious adverse events including deaths and infections. The FDA later inspected the study and issued a warning letter to the approving IRB, questioning the trial. Lessons for IRB members are to prioritize patient safety, scrutinize sponsor and protocol details, and maintain documents for at least two years.
Inf10 charlotte gastro_infographic
See how one GI practice in North Carolina achieved over half-million dollars a year in savings and other benefits after adopting NextGen Ambulatory EHR and Practice Management.
Aethlon receives government contract
Aethlon Medical news disclosure of government contract award to develop medical device to prevent sepsis in combat-injured soldiers.
Saor Commercialisation V2
The document discusses semantic interoperability in healthcare and SAOR's solution. It describes the current fragmented state of hospital information systems and vision for improved integration. SAOR offers a semantic mediation platform that can integrate different clinical systems like EPRs more robustly and flexibly than current HL7 engine approaches through use of ontologies. Plans are outlined to develop prototypes, conduct validation trials, and license the technology to software vendors and health services.
Plug and Play Electronic Patient Records
PPEPR software aims to enable plug-and-play electronic patient records by developing an intelligent automation system using semantics. It offers a solution to integrate different clinical systems like radiology and oncology more efficiently by validating, routing, and transforming message between systems. The current plans are to develop prototypes in 2006-2007 and conduct validation trials in 2008 while engaging clinical partners and seeking advisory board input.
ECOG-ACRIN Roster Update Form
This document provides instructions for updating a roster for the ECOG-ACRIN Cancer Research Group. It outlines the steps for research personnel to obtain a CTEP identification number and complete a roster update form to be added to the ECOG-ACRIN database. Physicians obtain a CTEP Investigator ID and non-physicians a CTEP Associate ID. The form requests name, contact, and institutional affiliation information as well as specialty, degrees, and CTEP ID for listing. It also provides options to serve as a registrar and instructions to submit completed forms by email or fax.
Judith Ngere_App Note Abstract
The document describes a study using the Agilent 6230 TOF mass spectrometer to screen for 15 drugs listed in the UK Drug Driving Law in blood samples. An all-ions MS/MS method was developed that utilized in-source fragmentation and an accurate mass MS/MS library to identify compounds through fragment matching down to a limit of detection of 2ng/mL, meeting or exceeding the threshold limits in the law.
Premarket Notification 510(k) for Biologics [Autosaved].pptx
The document summarizes the key aspects of the 510(k) premarket notification process for biologics. It explains that 510(k) is required to market a new device and demonstrates substantial equivalence to a legally marketed predicate device. The submission must include device descriptions, intended use, and clinical/nonclinical test results. There are three types of 510(k) submissions. The process involves FDA review within 90 days to determine substantial equivalence or request additional information. If cleared, the product can be marketed immediately.
K043503_VISX Slit Lamp Illuminator
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic device intended to facilitate inspection of the anterior eye segment. It consists of a slit illuminator and charger unit. Non-clinical testing showed compliance with electrical safety standards and no new safety concerns. The FDA determined it to be substantially equivalent to legally marketed predicate devices.
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...qserveconference2013
The document provides an overview of new and updated FDA regulations and processes for medical devices. It summarizes FDA classification systems and approval pathways, including new Refuse to Accept and electronic copy submission requirements. It also outlines changes to the de novo and pre-submission processes, as well as new guidance on Unique Device Identification and international symbols.Understanding FDA Requirements Medical Devices
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Understanding FDA Regulations
This presentation provides an overview of the FDA regulatory landscape for medical devices. It discusses the FDA structure and centers, the classification system for devices, and the approval pathways of 510(k) clearance and premarket approval. It also covers investigational devices, combination products, and user fees. The goal is to help organizations understand the FDA requirements for entering the US medical device market.
Davis reimbursement review
This document discusses reimbursement for vascular interventions and provides coding guidance for lower extremity peripheral interventions. It begins with basic reimbursement concepts like place of service, diagnosis and procedure codes. It then reviews inpatient vs outpatient criteria and key acronyms. Coding rules and hierarchies are presented for lower extremity interventions including the femoral/popliteal, iliac and tibial/peroneal territories. Medicare payment rates for 2013 are shown for common lower extremity codes.
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Device
Neuro-Stim Electro Acupuncture device and Electro Acupuncture Stimulator. The Electro Auricular Device or PENS (Percutaneous Electrical Nerve Stimulation). Neurostimulation pain therapy medical devices deliver a therapeutic electrical signal into auricular nerves to help release endorphins and provide pain relief.
https://www.laserspineinstitute.com/spinal_orthopedic_procedures/neurostim/
510 k
The document discusses the FDA 510(k) premarket notification process for medical devices. It explains that Class I, II, and III medical devices intended for commercial distribution in the US require FDA clearance obtained through a 510(k) or Premarket Approval (PMA). A 510(k) involves demonstrating that a new device is substantially equivalent to a predicate device already legally marketed in the US. The submission must provide device descriptions, intended use, performance testing results and labeling to establish safety and effectiveness.
Elexes medical consulting webinar- 510(k) Submissions
This webinar presentation provides an overview of the key elements of a 510(k) submission process for medical devices in the United States. It discusses the concept and types of 510(k) clearances, FDA review stages, considerations for performance and software testing, common questions, and tips for a successful 510(k). The presentation aims to help medical device companies understand the requirements and expectations for obtaining a 510(k) clearance from the FDA.
K120460_ Smartlux Therapy
This document summarizes a 510(k) submission for a light therapy system called SMARTLUX. SMARTLUX uses red, blue, and infrared light from interchangeable heads to treat various dermatological and musculoskeletal conditions. Performance testing shows it is substantially equivalent to legally marketed predicate devices. The FDA found SMARTLUX to be substantially equivalent and can be marketed for treating superficial lesions with 633nm light, acne with 415nm light, and muscle/joint pain with 830nm light.
Overview and update of chinese medical device regulation
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Foi and iig
The document discusses the FDA's Inactive Ingredient Guide (IIG), which lists inactive ingredients that are present in approved drug products. It provides information on obtaining the IIG and describes the contents and purpose of the guide. The IIG is intended to help identify inactive ingredients that may require less extensive review if they are already present in approved drug products for a particular route of administration. It lists ingredients alphabetically and provides information like routes of administration, CAS numbers, number of NDAs, and potency ranges.
5-MHRA(2).pdf
The MHRA has sent a letter to Peter Wei of Lotus Global Co Ltd confirming registration of Xiamen Jiqing Biomedical Technology Co., Ltd. as a manufacturer of in vitro diagnostic medical devices based on the information provided by Wei as their authorized representative. The letter notes that registration does not represent endorsement of the manufacturer's device classifications and that any changes to the registration information must be reported.
More Related Content
Similar to FDA-ECG
Premarket Notification 510(k) for Biologics [Autosaved].pptx
The document summarizes the key aspects of the 510(k) premarket notification process for biologics. It explains that 510(k) is required to market a new device and demonstrates substantial equivalence to a legally marketed predicate device. The submission must include device descriptions, intended use, and clinical/nonclinical test results. There are three types of 510(k) submissions. The process involves FDA review within 90 days to determine substantial equivalence or request additional information. If cleared, the product can be marketed immediately.
K043503_VISX Slit Lamp Illuminator
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic device intended to facilitate inspection of the anterior eye segment. It consists of a slit illuminator and charger unit. Non-clinical testing showed compliance with electrical safety standards and no new safety concerns. The FDA determined it to be substantially equivalent to legally marketed predicate devices.
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...qserveconference2013
The document provides an overview of new and updated FDA regulations and processes for medical devices. It summarizes FDA classification systems and approval pathways, including new Refuse to Accept and electronic copy submission requirements. It also outlines changes to the de novo and pre-submission processes, as well as new guidance on Unique Device Identification and international symbols.Understanding FDA Requirements Medical Devices
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Understanding FDA Regulations
This presentation provides an overview of the FDA regulatory landscape for medical devices. It discusses the FDA structure and centers, the classification system for devices, and the approval pathways of 510(k) clearance and premarket approval. It also covers investigational devices, combination products, and user fees. The goal is to help organizations understand the FDA requirements for entering the US medical device market.
Davis reimbursement review
This document discusses reimbursement for vascular interventions and provides coding guidance for lower extremity peripheral interventions. It begins with basic reimbursement concepts like place of service, diagnosis and procedure codes. It then reviews inpatient vs outpatient criteria and key acronyms. Coding rules and hierarchies are presented for lower extremity interventions including the femoral/popliteal, iliac and tibial/peroneal territories. Medicare payment rates for 2013 are shown for common lower extremity codes.
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Device
Neuro-Stim Electro Acupuncture device and Electro Acupuncture Stimulator. The Electro Auricular Device or PENS (Percutaneous Electrical Nerve Stimulation). Neurostimulation pain therapy medical devices deliver a therapeutic electrical signal into auricular nerves to help release endorphins and provide pain relief.
https://www.laserspineinstitute.com/spinal_orthopedic_procedures/neurostim/
510 k
The document discusses the FDA 510(k) premarket notification process for medical devices. It explains that Class I, II, and III medical devices intended for commercial distribution in the US require FDA clearance obtained through a 510(k) or Premarket Approval (PMA). A 510(k) involves demonstrating that a new device is substantially equivalent to a predicate device already legally marketed in the US. The submission must provide device descriptions, intended use, performance testing results and labeling to establish safety and effectiveness.
Elexes medical consulting webinar- 510(k) Submissions
This webinar presentation provides an overview of the key elements of a 510(k) submission process for medical devices in the United States. It discusses the concept and types of 510(k) clearances, FDA review stages, considerations for performance and software testing, common questions, and tips for a successful 510(k). The presentation aims to help medical device companies understand the requirements and expectations for obtaining a 510(k) clearance from the FDA.
K120460_ Smartlux Therapy
This document summarizes a 510(k) submission for a light therapy system called SMARTLUX. SMARTLUX uses red, blue, and infrared light from interchangeable heads to treat various dermatological and musculoskeletal conditions. Performance testing shows it is substantially equivalent to legally marketed predicate devices. The FDA found SMARTLUX to be substantially equivalent and can be marketed for treating superficial lesions with 633nm light, acne with 415nm light, and muscle/joint pain with 830nm light.
Overview and update of chinese medical device regulation
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Foi and iig
The document discusses the FDA's Inactive Ingredient Guide (IIG), which lists inactive ingredients that are present in approved drug products. It provides information on obtaining the IIG and describes the contents and purpose of the guide. The IIG is intended to help identify inactive ingredients that may require less extensive review if they are already present in approved drug products for a particular route of administration. It lists ingredients alphabetically and provides information like routes of administration, CAS numbers, number of NDAs, and potency ranges.
5-MHRA(2).pdf
The MHRA has sent a letter to Peter Wei of Lotus Global Co Ltd confirming registration of Xiamen Jiqing Biomedical Technology Co., Ltd. as a manufacturer of in vitro diagnostic medical devices based on the information provided by Wei as their authorized representative. The letter notes that registration does not represent endorsement of the manufacturer's device classifications and that any changes to the registration information must be reported.
Similar to FDA-ECG (13)
Premarket Notification 510(k) for Biologics [Autosaved].pptx
Premarket Notification 510(k) for Biologics [Autosaved].pptx
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...
Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 20...
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Device
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Device
Elexes medical consulting webinar- 510(k) Submissions
Elexes medical consulting webinar- 510(k) Submissions
Overview and update of chinese medical device regulation
Overview and update of chinese medical device regulation
FDA-ECG
- 1. Database Updated 5/08/2006 CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page Center for Devices and Radiological Health / CDRH FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH 510 (k) | Registration | Listing | Adverse Events | PMA | Classification | CLIA CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards New Search Back To Search Results 510(k) Premarket Notification Database Device Classification Name Electrode, Electrocardiograph 510(K) Number K041954 Regulation Number 870.2360 Device Name DISPOSABLE MONITORING ELECTRODES Applicant SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. 500 Airport Way Sandpoint, ID 83864 Contact Chris Healy Classification Product Code DRX Date Received 07/20/2004 Decision Date 09/15/2004 Decision Substantially Equivalent (SE) Classification Advisory Committee Cardiovascular Review Advisory Committee Cardiovascular Statement/Summary/Purged Status Summary Only Summary Summary Type Traditional Reviewed By Third Party No Expedited Review No 页码，1/1FDA > CDRH > 510(k) Premarket Notification Database Search 2006-6-1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=1...