510(k) Report

Devices descending from K012437

42 later devices reach Devilbiss Sleep Recorder Model # RM60 through their predicates, nearest generation first.

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