510(k) Report

Devices descending from DEN220073

3 later devices reach Revi System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240037Revi™ SystemBluewind Medical, Ltd.20242—
+2K253651Revi SystemBluewind Medical, Ltd.20260—
+2K252391Revi SystemBluewind Medical, Ltd.20250—