510(k) Report

Devices descending from K112822

6 later devices reach Sleepstrip II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173974DrowzleResonea, Inc.20195—
+2K231667Withings Sleep RxWithings20240—
+2K213360SleepCheckRxResapp Health20220—
+2K210480AcuPebble SAAcurable Limited20212—
+3K222950AcuPebble OX100Acurable Limited20231—
+4K243092AcuPebble Ox (200)Acurable Limited20250—