510(k) Report

Devices descending from K183559

5 later devices reach WatchPAT ONE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220095ANNE SleepSibel, Inc.20224—
+2K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+3K244027Sansa HsatHuxley Medical20252—
+4K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+4K252497Sansa HsatHuxley Medical20250—