510(k) Report

Devices descending from K130007

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+2K260050WRAP SystemHuneo, LLC20260—
+2K233438SleepStageMLBeacon Biosignals, Inc.20240—
+2K182227Esprit NovaNeurozone Msh Incorporated20190—
+2K162627EnsoSleepEnsodata, Inc.20179—
+3K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+3K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+3K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+3K221179SomnoMetryNeumetry Medical, Inc.20223—
+3K210034EnsoSleepEnsodata, Inc.20210—
+4K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+4K241288Noxturnal WebNox Medical Ehf20242—
+5K261747Report StudioBeacon Biosignals, Inc.20260—
+5K260585Noxturnal WebNox Medical Ehf20260—