510(k) Report

Devices descending from K873535

65 later devices reach Nicolet Expert Sleep/Wake Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961817B Smart Model 1Koven Technology, Inc.19970—
+1K955841Sleep System for Clinics & ResearchCompumedics Ptd, Ltd.199763—
+2K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited20101—
+2K072201Compumedics Somte PSG Recording SystemCompumedics Limited200848—
+2K072014VitascoreVitascore B.V.200740—
+2K022506Morpheus 1, Automated Sleep Study Scoring & Data Management SystemWidemed, Ltd.200329—
+2K984580Biosaca SystemBiosys AB (Publ)19991—
+3K230073OktiCompumedics Limited20230—
+3K192469Nox Sleep SystemNox Medical20194—
+3K112102Michele Sleep Scoring SystemsYounes Sleep Technologies201118—
+3K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+3K083620Somnolyzer 24X7The Siesta Group North America200925—
+3K082968Apneicare Connection Center/Internet AnalysisApneicare, LLC200939—
+3K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+3K991446Biosaca System, Model 800Biosys AB (Publ)19990—
+4K252330DeepRESPNox Medical Ehf20250—
+4K241960DeepRESPNox Medical Ehf20251—
+4K223539Dreem 3SBeacon Biosignals, Inc.20231—
+4K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+4K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+4K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+4K131994Somnolyzer 24X7Respironics, Inc.20135—
+4K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+4K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+4K111314Morpheus OXWidemed, Ltd.20110—
+4K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+5K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+5K242094Dreem 3SBeacon Biosignals, Inc.20240—
+5K142988Sleepware G3Respironics, Inc.20154—
+5K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+5K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+5K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+5K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+5K120447X4Advanced Brain Monitoring, Inc.201218—
+6K250851Hypnos (369054-200)Cadwell Industries, Inc.20250—
+6K202142Sleepware G3Respironics, Inc.20202—
+6K180608Lunoa SystemNightbalance BV20180—
+6K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+6K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+6K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+7K260050WRAP SystemHuneo, LLC20260—
+7K233403Flexset SystemZeto, Inc.20241—
+7K233438SleepStageMLBeacon Biosignals, Inc.20240—
+7K200705Nurochek SystemCryptych Pty, Ltd.20200—
+7K182227Esprit NovaNeurozone Msh Incorporated20190—
+7K172735WR19 SystemZeto, Inc.20183—
+7K170138NeuronauteBioserenity20170—
+7K162627EnsoSleepEnsodata, Inc.20179—
+7K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+8K260455New Wave SystemZeto, Inc.20260—
+8K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+8K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+8K221179SomnoMetryNeumetry Medical, Inc.20223—
+8K220056iSyncWaveiMediSync, Inc.20220—
+8K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+8K210034EnsoSleepEnsodata, Inc.20210—
+8K192753NeuralScan SystemMedeia, Inc.20203—
+8K171781eVox SystemEvoke Neuroscience, Inc.20176—
+9K253767UB ERP SystemUniversal Brain20260—
+9K241288Noxturnal WebNox Medical Ehf20242—
+9K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+9K221959Q21Neurofield, Inc.20230—
+9K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+10K261747Report StudioBeacon Biosignals, Inc.20260—
+10K260585Noxturnal WebNox Medical Ehf20260—