Created an account because I am a medical device engineer. You're mischaracterizing 510ks quite a bit. A 510k states that a new device has the same medical indication as a previous device, and you don't have to…
Created an account because I am a medical device engineer. You're mischaracterizing 510ks quite a bit. A 510k states that a new device has the same medical indication as a previous device, and you don't have to…