510(k) Report

Devices descending from K223163

3 later devices reach Sleepiz One+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254058DistaSense (TM) (v1)Life Detection Technologies20260—
+1K251364Sleepiz One+ (2.5)Sleepiz AG20251—
+2K253388Sleepiz One+ (Model 2.5)Sleepiz AG20260—