510(k) Report

Devices descending from K041816

59 later devices reach RTX3320PSTN Wireless Telehealth Gateway through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100427Fora GW 9014 Telehealth Gateway/TD-9014 Telehealth GatewayTaidoc Technology Corporation20101—
+1K100524Polytel (R) Apt Model: Pwa-08-01Polymap Wireless, LLC20100—
+1K062304DLM112 Daylink MonitorRtx Healthcare A/S20068—
+1K052343E-San Bluetooth CradleE-San Limited200525—
+1K050929The Hermes SystemPalaistra Systems, Inc.200545—
+2K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+2K091220Healthanywhere SystemHealthanywhere, an Igeacare System Company20092—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K071953RTX3370Rtx Healthcare A/S20073—
+2K062377Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc.200720—
+2K062215Confidant 2.0Confidant, Inc.200635—
+2K061328Think Positive Diabetes Management System (T+Diabetes System)E-San Limited200624—
+3K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc.20131—
+3K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+3K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+3K111932Iglucose SystemPositiveid Corporation20112—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K093789Intouch DiabetesSymcare Personalized Health Solutions, Inc.20100—
+3K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc.20104—
+3K091296Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09Polymap Wireless20090—
+3K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+3K090886RTX 3371Tunstall Healthcare20092—
+3K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc.20091—
+3K072698Confidant 2.5Confidant, Inc.200734—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K171406Optum TeleHealth ApplicationUnited Health Group, Inc.20170—
+4K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+4K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+4K132148S HealthSamsung Electronics Co., Ltd.20130—
+4K131739Nxstage Connected Health SystemNxstage Medical, Inc.20131—
+4K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+4K111922Vocare Myhealth TabletVocare, Inc.20110—
+4K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+4K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+4K110334Waldo Patient MonitorWaldo Health20111—
+4K101806Aidera Diasend SystemAidera AB20102—
+4K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc.20101—
+4K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc.20099—
+4K083221Aidera DiasendAidera AB20093—
+4K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG20090—
+4K083331Confidant, Model 2.6Confidant, Inc.20092—
+5K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+5K181991NxStage Connected Health SystemNxstage Medical, Inc.20180—
+5K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+5K132618Onetouch RevealLifescan, Inc.20130—
+5K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless20132—
+5K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+5K122333Mobilecare MonitorAframe Digital, Inc.20120—
+5K113446Vignet Telehealth ManagerVignet, Inc.20128—
+5K113493TCX-I Remote Care Management SystemBl Healthcare, Inc.20110—
+5K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+6K132930Myhealthpoint Telehealth ManagerEntra Health Systems20140—
+6K134004Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless20140—
+6K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+6K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc.20132—
+7K132173Family HealthwareSanitas, Inc.20140—