510(k) Report

Devices descending from K092003

4 later devices reach CPC Sleep Data Recorder, Model M1, and Application Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+2K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+3K252628CassieWesper, Inc.20260—
+3K231355AuroraEnsodata20240—