510(k) Report

Devices descending from K960925

41 later devices reach Northeast Monitoring DR180 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983576DR180-R/OxyNorth East Monitoring, Inc.199940—
+2K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.200339—
+3K090801Electronic House CallExpress MD Solutions, LLC20093—
+3K041308Remotenurse Patient Monitoring SystemWebvmc, LLC200434—
+4K102063Health-E-Connect SystemAlr Technologies20111—
+4K093895Ally Platform SystemContinuity Health Solutions20100—
+4K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+4K063008Health Check KioskXperex Corporation20074—
+4K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc.20057—
+5K233446AMC Health CareConsoleAmc Health20240—
+5K163664Health-e-Connect System with IDAAlr Technologies20170—
+5K151839AMC Health VitalCaregiving SystemAmc Health20161—
+5K143108HealthGuard-15Futrex, Inc.20150—
+5K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+5K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+5K113402Solohealth StationSolohealth, Inc.20120—
+5K111922Vocare Myhealth TabletVocare, Inc.20110—
+5K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+5K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+5K110334Waldo Patient MonitorWaldo Health20111—
+5K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+5K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc.20101—
+5K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+5K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+5K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+6K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+6K153600Consult Station TSH4D Sas20170—
+6K133997LG SmarthealthLg Electronics20140—
+6K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+6K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+6K132148S HealthSamsung Electronics Co., Ltd.20130—
+6K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+6K122333Mobilecare MonitorAframe Digital, Inc.20120—
+6K122285Tablet CommanderCardiocom, LLC20125—
+6K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+6K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+7K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+7K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+7K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+7K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+7K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—