510(k) Report

Devices descending from K211493

2 later devices reach Monarch Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.202511
+2K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.20260—