510(k) Report

Devices descending from K871748

124 later devices reach The Buddy System W/Optional Ecg Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964408Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc.1997123—
+2K033410Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd.200415—
+2K993643Nexsystem Ambulatory Patient Monitor Model Nex 100Nexan Telemed, Ltd.19990—
+2K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co.1999103—
+2K992478Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard, Healthcare Solutions Group199935—
+3K103214M3810A Philips Telemonitoring System with Edevice BRIDGED130Lifeline Systems, Inc.20103—
+3K082718Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.200814—
+3K041674The M3810A Philips Telemonitoring System with M3814A SPO2 UnitPhilips Medical Systems2004342
+3K040966Modification to Carematix Wellness SystemCarematix, Inc.200486—
+3K031840Carematix Wellness SystemCarematix, Inc.200390—
+3K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems200298—
+4K141706Ecare Coordinator (Ecc)Visicu, Inc.201422
+4K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+4K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+4K113446Vignet Telehealth ManagerVignet, Inc.20128—
+4K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+4K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+4K100508Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc.20102—
+4K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc.20099—
+4K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+4K090285Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd.20094—
+4K083046Fora Telehealth SystemTaidoc Technology Corporation20090—
+4K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+4K080091Modification to:Health Buddy ApplianceHealth Hero Network, Inc.20081—
+4K073038Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc.20086—
+4K070543Modification to Health Buddy ApplianceHealth Hero Network, Inc.20072—
+4K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc.200630—
+4K062662Telemedicine System Model VMS-01Medic4all (Israel), Ltd.20062—
+4K062127MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp)Medic4all (Israel), Ltd.20062—
+4K062304DLM112 Daylink MonitorRtx Healthcare A/S20068—
+4K061502MEDIC4ALL Telemedicine System VMS-01Medic4all (Israel), Ltd.20062—
+4K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc.200639—
+4K060504Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001Ideal Life, Inc.20065—
+4K052608Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc.20065—
+4K051470Remote Care Management Systems (RCMS)Bl Healthcare, Inc.200521—
+4K050929The Hermes SystemPalaistra Systems, Inc.200545—
+4K050567Health Buddy ApplianceHealth Hero Network, Inc.200540—
+4K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc.200445—
+4K041816RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S200459—
+5K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited20203—
+5K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+5K171029eCareCoordinatorVisicu, Inc.20171—
+5K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+5K132930Myhealthpoint Telehealth ManagerEntra Health Systems20140—
+5K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc.20131—
+5K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+5K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless20132—
+5K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+5K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc.20132—
+5K122333Mobilecare MonitorAframe Digital, Inc.20120—
+5K111922Vocare Myhealth TabletVocare, Inc.20110—
+5K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+5K110334Waldo Patient MonitorWaldo Health20111—
+5K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+5K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+5K100427Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth GatewayTaidoc Technology Corporation20101—
+5K100524Polytel (R) Apt Model: Pwa-08-01Polymap Wireless, LLC20100—
+5K093895Ally Platform SystemContinuity Health Solutions20100—
+5K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc.20101—
+5K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc.20104—
+5K091220Healthanywhere SystemHealthanywhere, an Igeacare System Company20092—
+5K091430Care Pal, Model CPW-10XDigio2 International Co., Ltd.20090—
+5K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+5K090801Electronic House CallExpress MD Solutions, LLC20093—
+5K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+5K080538Ideal Life Pod (Model Ilp 0001)Ideal Life, Inc.20084—
+5K073710Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies20082—
+5K071564Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems20075—
+5K071953RTX3370Rtx Healthcare A/S20073—
+5K062377Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc.200720—
+5K063484Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc.20064—
+5K062215Confidant 2.0Confidant, Inc.200635—
+5K052343E-San Bluetooth CradleE-San Limited200525—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K241368Sonicaid Team3Huntleigh Healthcare, Ltd.20252—
+6K222398Care Team PortalVivify Health, Inc.20230—
+6K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+6K171406Optum TeleHealth ApplicationUnited Health Group, Inc.20170—
+6K152645Dictum HealthDictum Health, Inc.20166—
+6K133997LG SmarthealthLg Electronics20140—
+6K132173Family HealthwareSanitas, Inc.20140—
+6K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+6K134004Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless20140—
+6K132148S HealthSamsung Electronics Co., Ltd.20130—
+6K131739Nxstage Connected Health SystemNxstage Medical, Inc.20131—
+6K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+6K122285Tablet CommanderCardiocom, LLC20125—
+6K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+6K120895Remote Presence SystemIntouch Health, Inc.20121—
+6K113493TCX-I Remote Care Management SystemBl Healthcare, Inc.20110—
+6K111932Iglucose SystemPositiveid Corporation20112—
+6K102063Health-E-Connect SystemAlr Technologies20111—
+6K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+6K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+6K091579Foresee HomeNotal Vision, Ltd.20094—
+6K090886RTX 3371Tunstall Healthcare20092—
+6K083221Aidera DiasendAidera AB20093—
+6K072698Confidant 2.5Confidant, Inc.200734—
+6K061328Think Positive Diabetes Management System (T+Diabetes System)E-San Limited200624—
+7K250777Sonicaid Team3Huntleigh Healthcare, Ltd.20251—