What is the US FDA 510K, and how can I obtain it in 2024? – do shockwave devices need fda 510k – regpro.us
The USFDA 510(k) process is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). Here are [...]