510(k) Report

Devices descending from K000068

569 later devices reach Compumedics E-Series Eeg System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited20101—
+1K050143Omnipro SystemMays and Associates, Inc.20050—
+1K021176Compumedics Somte SystemCompumedics Limited200395—
+1K021807Grass-Telefactor AS40 Amplifier SystemGrass Instrument Co.2002471—
+2K230073OktiCompumedics Limited20230—
+2K172711Comet-PLUSNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20172—
+2K073682Embletta GoldEmbla Systems, Inc.2008411
+2K072201Compumedics Somte PSG Recording SystemCompumedics Limited200848—
+2K052573Stardust IIRespironics, Inc.200502
+2K050425Aura-PSGAstro-Med, Inc.20055—
+2K050798Eclipse Neurological WorkstationAxon Systems, Inc.2005460—
+2K040194Compumedics Summit IPCompumedics USA, Ltd.200413—
+2K033978ADAMAstro-Med, Inc.20046—
+3K192469Nox Sleep SystemNox Medical20194—
+3K180290Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)201811
+3K122516Embletta MPREmbla Systems2013271
+3K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp.201113—
+3K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+3K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+3K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+3K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A.20084—
+3K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc.2006426—
+3K061113OrthomonAxon Systems, Inc.2006450—
+3K043132Universal XacttraceMedcare Flaga200410—
+4K252330DeepRESPNox Medical Ehf20250—
+4K241960DeepRESPNox Medical Ehf20251—
+4K223539Dreem 3SBeacon Biosignals, Inc.20231—
+4K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+4K203343Wesper LabWesper, Inc.20211—
+4K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG20200—
+4K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems20191—
+4K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+4K171384Micromed BRAIN QUICK systemMicromed S.P.A.201801
+4K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+4K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+4K161579Watch-PAT200UItamar Medical, Ltd.201720—
+4K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+4K151354Cervello STIMBlackrock Neuromed20162—
+4K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC20133—
+4K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+4K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+4K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+4K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+4K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+4K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+4K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+5K260050WRAP SystemHuneo, LLC20260—
+5K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+5K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc.20240—
+5K242094Dreem 3SBeacon Biosignals, Inc.20240—
+5K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+5K221816Wesper LabWesper, Inc.20230—
+5K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+5K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K191031NightOwlEctosense NV20205—
+5K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+5K180775Watch-PAT300Itamar Medical, Ltd.201812—
+5K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.20181—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+5K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+5K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+5K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+5K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+5K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+5K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+5K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+5K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+5K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+5K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+5K120447X4Advanced Brain Monitoring, Inc.201218—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K252628CassieWesper, Inc.20260—
+6K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+6K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+6K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—