510(k) Report

Devices descending from K971867

105 later devices reach Alice 4R System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+9K254042WatchPAT SWItamar Medical, Ltd.20260—
+9K244027Sansa HsatHuxley Medical20252—
+10K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+10K252497Sansa HsatHuxley Medical20250—