510(k) Report

Devices descending from K990522

61 later devices reach Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061908Nicoletone System V32 AmplifierViasys Neuro Care200619—
+1K042364Panbus Digital Eeg & Sleep Acquisition DevicesLamont Medical, Inc.20040—
+1K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.200339—
+2K143233Mitsar-EEGMitsar Co., Ltd.201511—
+2K103140Nicolet Wireless EegCarefusion 209, Inc.201171
+2K092625Wavestate NeuromonitorWavestate, Inc.20100—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K041308Remotenurse Patient Monitoring SystemWebvmc, LLC200434—
+3K231457SPARK ScanSpark Neuro, Inc.20230—
+3K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+3K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG20200—
+3K171781eVox SystemEvoke Neuroscience, Inc.20176—
+3K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H.20170—
+3K170441ElectroTekMobilemedtek201712
+3K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U.20171—
+3K151600R-40 EEG AmplifierLifelines, Ltd.20151—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+3K063008Health Check KioskXperex Corporation20074—
+3K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc.20057—
+4K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.20260—
+4K233446AMC Health CareConsoleAmc Health20240—
+4K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+4K212788Seer HomeSeer Medical Pty, Ltd.202201
+4K192753NeuralScan SystemMedeia, Inc.20203—
+4K172271Trackit T4 EEG AmplifierLifelines, Ltd.20180—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K151839AMC Health VitalCaregiving SystemAmc Health20161—
+4K143108HealthGuard-15Futrex, Inc.20150—
+4K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+4K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+4K113402Solohealth StationSolohealth, Inc.20120—
+4K111922Vocare Myhealth TabletVocare, Inc.20110—
+4K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+4K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+4K110334Waldo Patient MonitorWaldo Health20111—
+4K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+4K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc.20101—
+4K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+4K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+4K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+5K253767UB ERP SystemUniversal Brain20260—
+5K221959Q21Neurofield, Inc.20230—
+5K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+5K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+5K153600Consult Station TSH4D Sas20170—
+5K133997LG SmarthealthLg Electronics20140—
+5K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+5K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+5K132148S HealthSamsung Electronics Co., Ltd.20130—
+5K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+5K122333Mobilecare MonitorAframe Digital, Inc.20120—
+5K122285Tablet CommanderCardiocom, LLC20125—
+5K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+5K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+6K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+6K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+6K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—