510(k) Report

Devices descending from K112102

18 later devices reach Michele Sleep Scoring Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+1K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+1K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+2K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+2K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+2K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+3K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+4K260050WRAP SystemHuneo, LLC20260—
+4K233438SleepStageMLBeacon Biosignals, Inc.20240—
+4K182227Esprit NovaNeurozone Msh Incorporated20190—
+4K162627EnsoSleepEnsodata, Inc.20179—
+5K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+5K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+5K221179SomnoMetryNeumetry Medical, Inc.20223—
+5K210034EnsoSleepEnsodata, Inc.20210—
+6K241288Noxturnal WebNox Medical Ehf20242—
+7K261747Report StudioBeacon Biosignals, Inc.20260—
+7K260585Noxturnal WebNox Medical Ehf20260—