510(k) Database - 510(k) Premarket Notification
文章推薦指數： 80 %
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, ... Cleared/Approved In Vitro Products. QuickLinks:Skiptomainpagecontent SkiptoSearch SkiptoTopicsMenu SkiptoCommonLinks
延伸文章資訊
- 1510(k) Database - 510(k) Premarket Notification
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is a...
- 2Premarket Approval (PMA) - US Food and Drug Administration
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the s...
- 3Medical Device Databases - US Food and Drug Administration
For information on CDRH Databases, please visit: http://www.fda.gov/MedicalDevices/DeviceRegulat...
- 4Establishment Registration & Device Listing - US Food and ...
medical device manufacturers registered with FDA and; medical devices listed with FDA ... does no...
- 5Medical Device Databases | FDA
Manufacturers required to conduct PAS must complete the study as a condition of approval. This da...
