510(k) Report

Devices descending from K152040

1 later device reach X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—