3 ms·
It's a 510k "clearance", not an "approval". It's relatively cheap and all you have to do is show your thing (ECG in this case) is effectively the same as other
by yostrovs 8y ago
It's a 510k "clearance", not an "approval". It's relatively cheap and all you have to do is show your thing (ECG in this case) is effectively the same as other similar devices (older ECGs) for medical purposes.
- o_____________o 8y agoWas looking for this in the comments. The ambiguity there is abused by many companies on the fringes of consumer health and cosmetic products. > A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval