510K is a Pre-Market Notification (PMN) for new or modified medical devices

Description: 510K certifies that the medical device is at least as safe and effective as a predicate device Brief Introduction to 510k   What is 510K? 510K is called as Pre-Market Notification (PMN) and is applicable for new or modified medical devices for marketability in the United States of America. 510K clearance has to be […]