Transmitters And Receivers, Physiological Signal, Radiofrequency

FDA product code DRG · 180 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2910
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-11-22 – 2026-07-09

DRG 2026-07-09

UbiqVue™ 2AYe Cardiac System (UX2253)

Applicant Lifesignals, Inc.

K number K261569

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DRG 2026-01-22

Perin Health System (PHD80060-2)

Applicant Perin Health Devices, LLC

K number K252984

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DRG 2025-10-02

EasyTeleMed (2.0.2)

Applicant Ingeniars S.R.L.

K number K252440

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DRG 2025-06-04

TeleRehab Aermos Cardiopulmonary Rehabilitation

Applicant The ScottCare Corporation

K number K250259

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DRG 2025-05-16

iBSM

Applicant Iorbit Digital Technologies Private Limited

K number K243837

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DRG 2024-11-12

UbiqVue™ 2A Multi-parameter System (UX2550)

Applicant Lifesignals, Inc.

K number K242018

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DRG 2024-09-26

BioButton System

Applicant Biointellisense, Inc.

K number K241101

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DRG 2024-06-03

ANNE Chest

Applicant Sibel Health, Inc.

K number K240251

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DRG 2023-08-10

ANNE One

Applicant Sibel Health, Inc.

K number K223711

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DRG 2023-05-15

HD+12, HD+15

Applicant Cardioline S.P.A

K number K220526

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DRG 2023-03-17

Alio

Applicant Alio, Inc.

K number K223073

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DRG 2023-02-06

Care Team Portal

Applicant Vivify Health, Inc.

K number K222398

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DRG 2022-12-12

BioButton System

Applicant Biolntellisense, Inc.

K number K212957

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DRG 2022-11-22

ANNE Pediatric

Applicant Sibel, Inc.

K number K221530

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DRG 2022-07-15

ers2 - ergoline Rehabilitation System

Applicant Ergoline GmbH

K number K212883

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DRG 2022-06-23

EZYPRO ECG Recorder (Model: UG02)

Applicant Sigknow Biomedical Co., Ltd.

K number K213233

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DRG 2022-03-24

Alio Medical Remote Monitoring System

Applicant Graftworx, Inc. Dba Alio

K number K211365

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DRG 2022-02-03

LifePath Remote Patient Monitoring Platform

Applicant Elastic Care Incorporated

K number K211822

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DRG 2021-09-14

ANNE One

Applicant Sibel, Inc.

K number K211305

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DRG 2021-07-21

LifeSignals Multi-Parameter Remote Monitoring Platform

Applicant Lifesignals, Inc.

K number K202868

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DRG 2020-07-15

LifeSignals ECG Remote Monitoring Patch Platform

Applicant Lifesignals, Inc.

K number K200690

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DRG 2020-06-01

Vitls Platform

Applicant Vitls, Inc.

K number K191620

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DRG 2020-04-20

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)

Applicant Vitalconnect, Inc.

K number K193343

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DRG 2020-04-16

Philips Biosensor BX100

Applicant Philips Medical Systems

K number K192875

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DRG 2020-02-06

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20

Applicant Vitalconnect, Inc.

K number K192757

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DRG 2020-01-07

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

Applicant VivaLNK, Inc.

K number K191870

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DRG 2019-12-18

BioSticker System

Applicant Biointellisense, Inc.

K number K191614

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DRG 2019-06-12

Life Sensor Cardiac Monitor

Applicant Braveheart Wireless, Inc.

K number K191331

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DRG 2019-06-07

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20

Applicant Vitalconnect, Inc.

K number K190916

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DRG 2019-03-07

VitalConnect Platform, VitalPatch Biosensor

Applicant Vitalconnect, Inc.

K number K183078

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DRG 2019-01-24

Surveyor S2

Applicant Mortara Instrument, Inc.

K number K182297

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DRG 2018-10-22

Comarch e-Care Platform

Applicant Comarch Healthcare SA

K number K181248

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DRG 2018-10-03

Caretaker Remote Display App and Caretaker Software Library

Applicant Caretaker Medical, LLC

K number K181196

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DRG 2018-06-14

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)

Applicant Hmicro, Inc.

K number K172011

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DRG 2018-05-30

ScioCardio ECG Transmitter

Applicant Synergen Technology Labs, LLC

K number K171019

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DRG 2018-05-08

BioStamp nPoint

Applicant Mc10, Inc.

K number K173510

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DRG 2018-04-23

Patient Status Engine

Applicant Isansys Lifecare, Ltd.

K number K172329

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DRG 2017-11-07

Rooti Rx ECG Event Recorder, Rooti Link APP Software

Applicant Rooti Labs , Ltd.

K number K163694

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DRG 2017-11-02

VitalPatch® VitalConnect Platform

Applicant Vitalconnect, Inc.

K number K163453

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DRG 2017-08-18

Optum TeleHealth Application

Applicant United Health Group, Inc.

K number K171406

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DRG 2017-07-14

eCareCoordinator

Applicant Visicu, Inc.

K number K171029

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DRG 2017-06-23

Ossler Exam Scope

Applicant Lr Med, Inc.

K number K171188

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DRG 2017-06-02

VitalWatch Software User Interface

Applicant Vitalconnect, Inc.

K number K170973

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DRG 2017-03-24

FFR Link, FFR Signal Processing Module

Applicant Boston Scientific Corporation

K number K170204

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DRG 2016-12-21

TelePatch Cardiac Monitor

Applicant Medicomp, Inc.

K number K161916

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DRG 2016-06-03

LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream

Applicant Honeywell Hommed, LLC

K number K153719

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DRG 2013-12-20

PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300

Applicant St. Jude Medical Systems AB

K number K133587

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DRG 2013-12-12

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK

Applicant Medapps Inc., Dba Alere Connect

K number K132803

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DRG 2013-12-04

S HEALTH

Applicant Samsung Electronics Co., Ltd.

K number K132148

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DRG 2013-11-26

INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC

Applicant Philips Medizin Systeme Boeblingen GmbH

K number K131913

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DRG 2013-10-23

OPTUM TELEHEALTH APPLICATION

Applicant Optumhealth Care Solutions, Inc.

K number K130971

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DRG 2013-08-09

INTEL-GE CARE INNOVATIONS CONNECT RCM

Applicant Intel-Ge Care Innovations, LLC

K number K130821

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DRG 2013-07-30

MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM

Applicant Medapps Inc., Dba Alere Connect

K number K124000

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DRG 2013-07-30

VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM

Applicant Cello Partnership D/B/A Verizon Wireless

K number K122458

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DRG 2013-07-15

CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION

Applicant Constant Care, LLC

K number K130360

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DRG 2013-07-08

AMBIO REMOTE HEALTH MONITORING SYSTEM

Applicant Arrayent Health, LLC D/B/A Ambio Health

K number K130676

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DRG 2013-06-20

PHYSIOLOGICAL DATA PROCESSOR

Applicant Zephyr Technology Corporation

K number K122763

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DRG 2013-06-04

MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE

Applicant Intel-Ge Care Innovations, LLC

K number K130290

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DRG 2013-01-16

WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM

Applicant Sanitas, Inc.

K number K123671

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DRG 2012-11-20

REMOTE PRESENCE SYSTEM, MODEL RP-VITA

Applicant Intouch Health, Inc.

K number K123229

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DRG 2012-11-19

MOBILECARE MONITOR

Applicant Aframe Digital, Inc.

K number K122333

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DRG 2012-08-14

TABLET COMMANDER

Applicant Cardiocom, LLC

K number K122285

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DRG 2012-07-26

ICP TRIAGEMANAGER

Applicant Emergo Europe Consulting BV

K number K122095

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DRG 2012-07-18

CONNECTED CARE MOBILE APPLICATION

Applicant Watermark Medical

K number K120325

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DRG 2012-07-16

ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)

Applicant Elcam Medical Acal

K number K120253

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DRG 2012-07-16

VIGNET TELEHEALTH MANAGER

Applicant Vignet, Inc.

K number K113446

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DRG 2012-07-03

CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM

Applicant Constant Care, LLC

K number K120941

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DRG 2012-06-08

MIPAL

Applicant Watermark Medical

K number K120470

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DRG 2012-05-24

REMOTE PRESENCE SYSTEM

Applicant Intouch Health, Inc.

K number K120895

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DRG 2012-05-03

3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM

Applicant 3M Company

K number K120704

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DRG 2012-01-24

GENESIS TOUCH SYSTEM

Applicant Honeywell Hommed, LLC

K number K112858

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DRG 2011-12-21

TCX-I REMOTE CARE MANAGEMENT SYSTEM

Applicant Bl Healthcare, Inc.

K number K113493

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DRG 2011-12-02

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM

Applicant Medapps, Inc.

K number K112559

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DRG 2011-12-02

VOCARE MYHEALTH TABLET

Applicant Vocare, Inc.

K number K111922

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DRG 2011-10-21

AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

Applicant St. Jude Medical Systems AB

K number K111854

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DRG 2011-10-06

ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)

Applicant Ascot Technologies, Inc.

K number K103643

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DRG 2011-08-03

TELEMEDCARE HEALTH MONITOR

Applicant Telemedcare Pty, Ltd.

K number K103796

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DRG 2011-07-05

WIRELESS MONITORING SYSTEM

Applicant Carefusion 303, Inc.

K number K110809

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DRG 2011-04-12

WALDO PATIENT MONITOR

Applicant Waldo Health

K number K110334

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DRG 2011-02-08

INTEL HEALTH GUIDE

Applicant Intel Corporation Digital Health Group

K number K103276

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DRG 2010-12-17

NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION

Applicant Nihon Kohden Corp.

K number K102106

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DRG 2010-12-01

M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130

Applicant Lifeline Systems, Inc.

K number K103214

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DRG 2010-09-03

3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

Applicant 3M Company

K number K101834

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DRG 2010-06-29

MODIFICATION TO INTEL HEALTH GUIDE PHS6000

Applicant Intel Corp.

K number K101178

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DRG 2010-06-11

GENESIS DM MODEL: 6053000A1

Applicant Honeywell Hommed, LLC

K number K101242

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DRG 2010-05-28

FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY

Applicant Taidoc Technology Corporation

K number K100427

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DRG 2010-05-24

POLYTEL(R) APT MODEL: PWA-08-01

Applicant Polymap Wireless, LLC

K number K100524

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DRG 2010-05-20

ALLY PLATFORM SYSTEM

Applicant Continuity Health Solutions

K number K093895

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DRG 2010-05-10

BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM

Applicant Bl Healthcare, Inc.

K number K101078

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DRG 2010-05-05

CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

Applicant Carematix, Inc.

K number K100508

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DRG 2009-11-27

CERNER CAREAWARE IBUS

Applicant Cerner Corp.

K number K093134

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DRG 2009-10-26

SAVI WIRELESS, MODEL PM500

Applicant Medicomp, Inc.

K number K091696

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DRG 2009-09-21

HEALTHANYWHERE SYSTEM

Applicant Healthanywhere, an Igeacare System Company

K number K091220

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DRG 2009-09-10

ALCATEL-LUCENT TELEHEATH MANAGER

Applicant Alcatel-Lucent Canada, Inc.

K number K092635

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DRG 2009-08-21

CARE PAL, MODEL CPW-10X

Applicant Digio2 International Co., Ltd.

K number K091430

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DRG 2009-07-15

MODIFICATION TO MEDICOMPASS CONNECT

Applicant Imetrikus, Inc.

K number K091021

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DRG 2009-06-05

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM

Applicant Medapps, Inc.

K number K083862

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DRG 2009-04-15

RTX 3371

Applicant Tunstall Healthcare

K number K090886

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DRG 2009-04-08

ELECTRONIC HOUSE CALL

Applicant Express MD Solutions, LLC

K number K090801

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DRG 2009-03-13

HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM

Applicant Hospira, Inc.

K number K090610

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