FDA Product Code
FDA Product Code DSI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 398 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 | Traditional | PDF ↗ |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | 2025-07-29 | Traditional | PDF ↗ |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-30 | Traditional | PDF ↗ |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2023-10-06 | Abbreviated | PDF ↗ |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023-08-30 | Traditional | PDF ↗ |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | 2020-04-09 | Special | PDF ↗ |
| K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | 2020-03-26 | Traditional | PDF ↗ |
| K190574 | Patient Assistant Model PA97000 | Medtronic, Inc. | 2019-09-24 | Traditional | PDF ↗ |
| K182532 | Liba3 System | National Cardiac, Inc. | 2019-05-15 | Traditional | PDF ↗ |
| K181658 | MobileECG 2 BT | Memtec Corporation | 2019-03-26 | Traditional | PDF ↗ |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | 2018-07-11 | Abbreviated | PDF ↗ |
| K173170 | Epicardia Anywhere | Medicomp, Inc. | 2018-01-10 | Special | PDF ↗ |
| K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | 2016-07-22 | Special | PDF ↗ |
| K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | 2016-05-25 | Traditional | PDF ↗ |
| K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | 2016-04-22 | Abbreviated | PDF ↗ |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016-04-08 | Abbreviated | PDF ↗ |
| K151835 | Vital Signs Patch System | Lifewatch Technologies , Ltd. | 2016-02-05 | Special | PDF ↗ |
| K151269 | ECG Mini System Continuous ECG Monitor and Arrhythmia Detector | Lifewatch Technologies , Ltd. | 2016-01-15 | Traditional | PDF ↗ |
| K152491 | MoMe Software Platform | Infobionic, Inc. | 2015-12-17 | Traditional | PDF ↗ |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | Medicalgorithmics S.A. | 2015-10-08 | Special | PDF ↗ |
| K151188 | BodyGuardian Remote Monitoring System | Preventice | 2015-09-17 | Traditional | PDF ↗ |
| K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector | Lifewatch Technologies , Ltd. | 2015-09-11 | Traditional | PDF ↗ |
| K151681 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 | Special | PDF ↗ |
| K150117 | Medtronic Patient Asistant | Medtronic, Inc. | 2015-05-27 | Traditional | PDF ↗ |
| K150310 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-05-13 | Special | PDF ↗ |
| K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015-03-12 | Traditional | PDF ↗ |
| K141441 | MENNTOR X7 | Mennen Medical , Ltd. | 2015-01-09 | Traditional | PDF ↗ |
| K132407 | VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) | Lifewatch Technologies , Ltd. | 2014-12-19 | Traditional | PDF ↗ |
| K142180 | TELESENSE | Scottcare Corporation | 2014-12-12 | Traditional | PDF ↗ |
| K140548 | CORCAM HEART MONITOR | Corcam Technologia, SA | 2014-05-23 | Traditional | PDF ↗ |
| K131000 | V-PATCH SYSTEM | Intelesens Limited | 2014-01-08 | Traditional | PDF ↗ |
| K124060 | MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | Medicalgorithmics S.A. | 2013-02-21 | Abbreviated | PDF ↗ |
| K121197 | BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT | Preventice, Inc. | 2012-08-10 | Traditional | PDF ↗ |
| K112921 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | Medicalgorithmics S.A. | 2012-05-16 | Abbreviated | PDF ↗ |
| K120774 | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT | Welch Allyn, Inc. | 2012-04-10 | Special | PDF ↗ |
| K113125 | INTELLIVUE MX40 PATIENT MONITOR | Philips Medical Systems | 2011-11-17 | Special | PDF ↗ |
| K111160 | INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) | Intricon Datrix Corporation | 2011-08-01 | Traditional | PDF ↗ |
| K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR | Tz Medical, Inc. | 2011-06-13 | Abbreviated | PDF ↗ |
| K103764 | REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 | Medtronic, Inc. | 2011-05-04 | Traditional | PDF ↗ |
| K110499 | CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2011-04-06 | Special | PDF ↗ |
| K103142 | SPACELABS MULTI-PARAMETER MODULE | Spacelabs Healthcare, Inc. | 2011-03-03 | Special | PDF ↗ |
| K102111 | MEDICAL MAGNETIC TAPE RECORDER | Wpr Medical AS | 2010-12-07 | Traditional | PDF ↗ |
| K101703 | MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 | Card Guard Scientific Survival , Ltd. | 2010-07-13 | Special | PDF ↗ |
| K101639 | CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2010-06-25 | Special | PDF ↗ |
| K093766 | VITALOGIK 6000/6500 | Mennen Medical , Ltd. | 2010-05-07 | Special | PDF ↗ |
| K100155 | TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM | Biomedical Systems Corp. | 2010-04-20 | Abbreviated | PDF ↗ |
| K092947 | TELESENTRY, MODEL TS01 | Scottcare Corporation | 2010-02-26 | Traditional | PDF ↗ |
| K091927 | INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-11-03 | Traditional | PDF ↗ |
| K091971 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM | Corventis, Inc. | 2009-08-27 | Special | PDF ↗ |
| K090037 | MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG | Medicalgorithmics SP Z.O.O. | 2009-05-22 | Abbreviated | PDF ↗ |
| K090834 | EPICARDIA 5000 | Medicomp, Inc. | 2009-05-15 | Special | PDF ↗ |
| K083287 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM | Corventis, Inc. | 2009-02-03 | Abbreviated | PDF ↗ |
| K083517 | INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-01-16 | Special | PDF ↗ |
| K082475 | REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 | Medtronic, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K082633 | INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008-10-03 | Special | PDF ↗ |
| K081444 | BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM | Braemar, Inc. | 2008-07-31 | Traditional | PDF ↗ |
| K081257 | CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2008-05-29 | Special | PDF ↗ |
| K071889 | DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE | GE Healthcare | 2008-05-19 | Special | PDF ↗ |
| K071995 | CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2007-12-18 | Traditional | PDF ↗ |
| K073140 | VITALOGIK MODEL 4000/4500 | Mennen Medical , Ltd. | 2007-11-21 | Special | PDF ↗ |
| K071641 | REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) | Medtronic, Inc. | 2007-11-21 | Traditional | PDF ↗ |
| K071655 | REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 | Medtronic, Inc. | 2007-11-21 | Traditional | PDF ↗ |
| K071805 | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX | Datascope Corp. | 2007-09-25 | Abbreviated | PDF ↗ |
| K062976 | MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER | Ge Medical Systems Information Technologies | 2007-03-16 | Special | PDF ↗ |
| K070260 | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 | Philips Medical Systems | 2007-02-23 | Special | PDF ↗ |
| K053263 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 | Cardionet, Inc. | 2006-04-25 | Abbreviated | PDF ↗ |
| K052288 | VITALOGIK | Mennen Medical , Ltd. | 2005-12-20 | Special | PDF ↗ |
| K052160 | ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) | Welch Allyn, Inc. | 2005-12-16 | Abbreviated | PDF ↗ |
| K050919 | LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P | Analogic Corp. | 2005-06-14 | Abbreviated | PDF ↗ |
| K050605 | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 | Spacelabs Medical, Inc. | 2005-05-03 | Special | PDF ↗ |
| K050175 | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 | Spacelabs Medical, Inc. | 2005-03-04 | Special | PDF ↗ |
| K024213 | SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 | Siemens Medical Solutions USA, Inc. | 2004-03-23 | Traditional | PDF ↗ |
| K033305 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM | Draeger Medical Systems, Inc. | 2003-10-31 | Special | PDF ↗ |
| K032858 | THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. | Philips Medizin Systeme Boblingen GmbH | 2003-10-10 | Special | PDF ↗ |
| K031433 | SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS | Siemens Medical Solutions USA, Inc. | 2003-08-19 | Special | PDF ↗ |
| K032370 | CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION | Ge Medical Systems Information Technologies | 2003-08-13 | Special | PDF ↗ |
| K023798 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2002-12-03 | Special | PDF ↗ |
| K020550 | PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX | Datascope Corp. | 2002-08-28 | Traditional | PDF ↗ |
| K022453 | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM | Welch Allyn Protocol, Inc. | 2002-08-21 | Special | PDF ↗ |
| K013046 | COSMOS SYSTEM | Spacelabs Medical, Inc. | 2002-08-21 | Traditional | PDF ↗ |
| K021376 | DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE | Datex-Ohmeda | 2002-07-24 | Traditional | PDF ↗ |
| K021097 | QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 | Spacelabs Medical, Inc. | 2002-06-28 | Traditional | PDF ↗ |
| K021300 | MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B | Philips Medical Systems | 2002-05-08 | Special | PDF ↗ |
| K021251 | ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. | Philips Medical Systems | 2002-05-07 | Special | PDF ↗ |
| K012467 | SOLAR 8000M SYSTEM | General Electric Medical Systems Information Techn | 2002-02-11 | Traditional | PDF ↗ |
| K002604 | CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM | Invivo Research, Inc. | 2002-02-07 | Traditional | PDF ↗ |
| K020084 | FUKUDA DENSHI DYNASCOPE MODEL DS-5700 | Fukuda Denshi USA, Inc. | 2002-02-06 | Special | PDF ↗ |
| K012241 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 | Cardionet, Inc. | 2002-02-01 | Traditional | PDF ↗ |
| K014159 | PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR | Philips Medical Systems, Inc. | 2002-01-18 | Special | PDF ↗ |
| K012336 | MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 | Medical Data Electronics | 2001-10-03 | Special | PDF ↗ |
| K011339 | QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 | Spacelabs Burdick, Inc. | 2001-08-20 | Traditional | PDF ↗ |
| K012461 | SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2001-08-17 | Special | PDF ↗ |
| K011784 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2001-08-16 | Special | PDF ↗ |
| K011824 | AGILENT M2636B TELEMON B MONITOR (TELEMON B) | Agilent Technologies, Inc. | 2001-07-02 | Special | PDF ↗ |
| K001120 | ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2001-05-08 | Traditional | PDF ↗ |
| K002758 | AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A | Agilent Technologies Deutschland GmbH | 2001-02-22 | Traditional | PDF ↗ |
| K002068 | ORG-9200A | Nihon Kohden America, Inc. | 2001-02-08 | Traditional | PDF ↗ |
| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | Quinton, Inc. | 2001-01-25 | Abbreviated | PDF ↗ |
| K003246 | SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION | Siemens Medical Solutions USA, Inc. | 2000-12-21 | Special | PDF ↗ |
| K003179 | SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM | Siemens Medical Solutions USA, Inc. | 2000-11-09 | Special | PDF ↗ |
Product code DSI · Class II · Cardiovascular. Data: openFDA.