I recently did a writeup [1] on the 510(k) FDA clearance process (which cleared this device for market).
Basically this device was cleared through a DAG of other devices that were "substantially equivalent". I made a website to visualize these relationships, and any recalls that occurred in the parent devices. If anyone is curious about this particular device, see here [2]
Basically this device was cleared through a DAG of other devices that were "substantially equivalent". I made a website to visualize these relationships, and any recalls that occurred in the parent devices. If anyone is curious about this particular device, see here [2]
[1] https://wcedmisten.fyi/post/medical-device-analysis/
[2] https://www.510k.fyi/devices/?id=K232380 (click on "Predicate ancestry graph")