510(k) Report

Devices descending from K220095

4 later devices reach ANNE Sleep through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+2K244027Sansa HsatHuxley Medical20252—
+3K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+3K252497Sansa HsatHuxley Medical20250—