510(k) Report

Devices descending from K962103

45 later devices reach Bio-Logic Sleepscan Product with Built-in Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052066Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp.200552
+1K012437Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc.200242—
+1K983072Ambulatory Eeg/Sleep Recorder and Accessories, Model # SSR3201Nihon Kohden America, Inc.19980—
+2K093728BE Micro, TreaEb Neuro S.P.A.20104—
+2K080375RMX Physiological Data RecorderS.L.P., Ltd.20080—
+2K040595ALICE 5Respironics, Inc.2004401
+3K201054SOMNOscreen plusSomnomedics GmbH20204—
+3K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+3K142988Sleepware G3Respironics, Inc.20154—
+3K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc.20143—
+3K111055Galaxy System; JupiterPersonal Health Institute International20110—
+3K112102Michele Sleep Scoring SystemsYounes Sleep Technologies201118—
+3K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+3K061996Sandman PocketEb Neuro S.P.A.20067—
+4K250851Hypnos (369054-200)Cadwell Industries, Inc.20250—
+4K241288Noxturnal WebNox Medical Ehf20242—
+4K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH20240—
+4K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+4K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+4K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+4K202142Sleepware G3Respironics, Inc.20202—
+4K180269Cadwell Apollo SystemCadwell Industries, Inc.20182—
+4K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+4K111314Morpheus OXWidemed, Ltd.20110—
+4K082853Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc.20090—
+4K083874GalaxyRespironics Inc., Sleep & Home Respiratory Group20090—
+4K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+5K261747Report StudioBeacon Biosignals, Inc.20260—
+5K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+5K260585Noxturnal WebNox Medical Ehf20260—
+5K241960DeepRESPNox Medical Ehf20251—
+5K201819Cadwell Apollo SystemCadwell Industries, Inc.20201—
+5K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+5K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+6K252330DeepRESPNox Medical Ehf20250—
+6K221959Q21Neurofield, Inc.20230—
+6K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+7K260050WRAP SystemHuneo, LLC20260—
+7K233438SleepStageMLBeacon Biosignals, Inc.20240—
+7K182227Esprit NovaNeurozone Msh Incorporated20190—
+7K162627EnsoSleepEnsodata, Inc.20179—
+8K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+8K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+8K221179SomnoMetryNeumetry Medical, Inc.20223—
+8K210034EnsoSleepEnsodata, Inc.20210—