510(k) Report

Devices descending from K153412

13 later devices reach Sleep Profiler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260050WRAP SystemHuneo, LLC20260—
+1K233438SleepStageMLBeacon Biosignals, Inc.20240—
+1K182227Esprit NovaNeurozone Msh Incorporated20190—
+1K162627EnsoSleepEnsodata, Inc.20179—
+2K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+2K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+2K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+2K221179SomnoMetryNeumetry Medical, Inc.20223—
+2K210034EnsoSleepEnsodata, Inc.20210—
+3K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+3K241288Noxturnal WebNox Medical Ehf20242—
+4K261747Report StudioBeacon Biosignals, Inc.20260—
+4K260585Noxturnal WebNox Medical Ehf20260—