510(k) Report

Devices descending from K163696

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+2K252628CassieWesper, Inc.20260—
+2K231355AuroraEnsodata20240—