Upload others
View 2
Download 0
Embed Size (px) 344 x 292 429 x 357 514 x 422 599 x 487
Citation preview
Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at [email protected]
Update on CDRH Informatics/UDI Work
processed under FOIA Request #2015-4874; Released by CDRH on 07-25-2016. Questions? Contact FDA/CDRH/OCE/DID at [email protected] or call 301-796-8118. " Loads and primes
510k Endoblate K072383
Medical device regulations 510k
( Picture Archiving and Communication System ) FDA 510K #K072637
The CDRH Software Message (October 19, 2002)
Traction Training and Enhancements at FDA - CDRH
The “New” 510k
Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at [email protected]
DTN-510K User Manual V1.3e Rev03
(Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to
CDRH Regulatory Research - Food and Drug … First 150 things you see in a hospital are probably Medical Devices CDRH in Perspective • CDRH oversees: – 175,000 medical devices
Department of Biomedical Engineering, University of ... · Abbreviated 510k Special 510k ... vs direct patient benefit (less death from heart disease). ... Special 510(k)
SPIROX 510K Approval
Optovue iVue 510k Summary_TN
Questions? Contact FDA/CDRH/OCE/DID at CDRH … › CDRH510K › K033967.pdf · Records processed under FOIA Request # 2015-6830; Released by CDRH on 11-18-2015 Contact FDA/CDRH/OCE/DID
Mi Caja de Herramientas TIC CDRH
Premarket Notification 510K Submissions for Medical
Records Processed under FOIA Request # 2015-8140… · Records Processed under FOIA Request # 2015-8140; Released by CDRH on 11-23-2015 Questions? Contact FDA/CDRH/OCE/DID at [email protected]
FDA 510K Clearance Documentation K041334 AlcoMate Drug Testing Kits
FDA Guidance Risk Benefit 510k[1]
Drug Testing, Guidance_ CDRH
Traditional 510k application - Polymeric Surgical Mesh
AirFit F20 (Newcaslte) User Guide AMER - 510K
CDRH, Congress and the 510(k) Process
Staple Foods Nutrition 3102 Unit 2. “Staple” Staple FoodsGrocery staples
510k Guidance 1
CDRH Vision - Total Product Life Cycle
Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at [email protected]
![FDA Guidance Risk Benefit 510k[1]](https://img.dokumen.tips/doc/110x75/577d1d7c1a28ab4e1e8c5d17/fda-guidance-risk-benefit-510k1.jpg)
