CE Marking of Medical Thermometer
Different types of Thermometers, Classification and Conformity assessment and routes for MDR CE Mark...
Substantial Equivalence
Substantial Equivalence is the demonstration that a new device, compared to a predicate device for t...
Covid 19 Emergency use Devices and FDA Registration and Listing Information
# Product Nature Product Code Approval 1 Surgical Face Mask Sterile / Non-Sterile FXX ...
Abbreviated 510k & Guidance
The medical devices for which the 510k or premarket notification is required from the US FDA before ...
FDA 510(k) Summary or Statement
FDA 510(k) Summary or Statement is part of the 510(k) file of a medical device that requires the Pr...
Traditional 510k
The Traditional 510k is one of the three types of the 510k in the US FDA. This type of 510k can be u...