510(k) Report

Devices descending from K082968

39 later devices reach Apneicare Connection Center/Internet Analysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+2K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+2K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+2K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+2K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+2K120447X4Advanced Brain Monitoring, Inc.201218—
+3K180608Lunoa SystemNightbalance BV20180—
+3K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+3K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+3K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+3K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+4K260050WRAP SystemHuneo, LLC20260—
+4K233403Flexset SystemZeto, Inc.20241—
+4K233438SleepStageMLBeacon Biosignals, Inc.20240—
+4K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+4K200705Nurochek SystemCryptych Pty, Ltd.20200—
+4K182227Esprit NovaNeurozone Msh Incorporated20190—
+4K172735WR19 SystemZeto, Inc.20183—
+4K170138NeuronauteBioserenity20170—
+4K162627EnsoSleepEnsodata, Inc.20179—
+4K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+5K260455New Wave SystemZeto, Inc.20260—
+5K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+5K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+5K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+5K221179SomnoMetryNeumetry Medical, Inc.20223—
+5K220056iSyncWaveiMediSync, Inc.20220—
+5K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+5K210034EnsoSleepEnsodata, Inc.20210—
+5K192753NeuralScan SystemMedeia, Inc.20203—
+5K171781eVox SystemEvoke Neuroscience, Inc.20176—
+6K253767UB ERP SystemUniversal Brain20260—
+6K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+6K241288Noxturnal WebNox Medical Ehf20242—
+6K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+6K221959Q21Neurofield, Inc.20230—
+6K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+7K261747Report StudioBeacon Biosignals, Inc.20260—
+7K260585Noxturnal WebNox Medical Ehf20260—