| mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) (K253384) | Seers Technology Co., Ltd. | 2026-06-25 |
| ZywieZ3 Sensor & Adhesive (K252839) | Zywie, Inc. | 2026-06-18 |
| HeartBeam AIMIGo(TM) System (K231424) | Heartbeam, Inc. | 2024-12-13 |
| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |
| Eclipse MINI Model 98900 (K212317) | Spacelabs Healthcare, Ltd. | 2022-11-07 |
| Biotres (K222017) | Biotricity | 2022-07-28 |
| Q Patch (K210758) | Medicalgorithmics S.A. | 2022-06-02 |
| Biotres (K211709) | Biotricity | 2022-01-19 |
| Eclipse PRO (K211651) | Spacelabs Healthcare, Ltd. | 2021-11-22 |
| Integrated CardioRespiratory System (K173156) | Sensydia, Inc. | 2018-06-08 |
| NR Recorder (K161062) | Norav Medical GmbH | 2016-06-13 |
| H3+ Holter Recorder (K152626) | Mortara Instrument, Inc. | 2016-02-26 |
| DR300 HOLTER MONITOR (K142424) | North East Monitoring, Inc. | 2014-11-25 |
| DMS 300-2W HOLTER ECG RECORDER (K133014) | Diagnostic Monitoring Software | 2014-05-19 |
| BRAEMAR CARDIOKEY HOLTER RECORDER (K130294) | Braemar Manufacturing, LLC | 2013-10-16 |
| SEER 1000 (K130785) | Getemed Medizin- Und Informationstechnik AG | 2013-07-26 |
| CARDIOMEM (K122272) | Getemed Medizin- Und Informationstechnik AG | 2013-03-28 |
| EZSLEEP SLEEP QUALITY RECORDER (K112573) | Platinum Team Co., Ltd. | 2012-03-22 |
| INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER (K112601) | Intricon Datrix Corporation | 2011-11-09 |
| MH1 MICROHOLTER RECORDER (K101969) | Exelys, LLC | 2011-02-04 |
| KENZ CARDY302 MAX (K101024) | Suzuken Co., Ltd. | 2011-01-06 |
| MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS (K102723) | Memtec Corp. | 2010-12-09 |
| BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS (K100310) | BTL Industries, Inc. | 2010-10-13 |
| ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 (K100266) | Camntech, Ltd. | 2010-04-29 |
| CHROMA, MODEL: RZ153C (K083382) | Scottcare Corporation | 2009-08-13 |
| WALK400H (K091054) | Et Medical Devices Spa | 2009-07-27 |
| AUDICOR, HEMO AMBULATORY MONITOR (K073545) | Inovise Medical, Inc. | 2008-09-09 |
| E3-80 PORTABLE ECG RECORDER & ANALYZER (K071085) | Micro-Star International Co., Ltd. | 2007-10-03 |
| DL900 SERIES HOLTER RECORDER (K071733) | Braemar, Inc. | 2007-07-24 |
| CARDIOMEM CM 3000-12BT (K063042) | Getemed Medizin- Und Informationstechnik AG | 2007-05-30 |
| AUTO DETECT FOR TELAHEART DR200/E-A (K070014) | North East Monitoring, Inc. | 2007-05-25 |
| MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER (K071011) | Braemar, Inc. | 2007-04-27 |
| DMS 300-2, 300-3 AND 300-4 (K062959) | Diagnostic Monitoring Software | 2006-10-16 |
| TELAHEART DIGITAL RECORDER (K061293) | North East Monitoring, Inc. | 2006-08-25 |
| CARDIOMEM CM 3000-12 (K051686) | Getemed Medizin- Und Informationstechnik AG | 2005-07-14 |
| SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM (K050731) | Ge Medical Systems Information Technologies | 2005-05-19 |
| HOLTER RECORDER H3+ (K043010) | Mortara Instrument, Inc. | 2005-02-25 |
| BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER (K042469) | Braemar, Inc. | 2004-10-06 |
| SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER (K041901) | North East Monitoring, Inc. | 2004-08-31 |
| RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 (K032882) | Recom Managed Systems, Inc. | 2004-01-28 |
| DIGITAL AMBULATORY ECG (HOLTER) RECORDER (K031074) | Datrix | 2003-10-15 |
| CLICK HOLTER (K032276) | Remco Italia S.P.A. | 2003-08-27 |
| SPIDERVIEW (K032466) | Ela Medical, Inc. | 2003-08-22 |
| ER800 SERIES ECG EVENT RECORDER (K030856) | Braemar Corp. | 2003-03-28 |
| SEER LIGHT COMPACT DIGITAL HOLTER RECORDER (K021470) | General Electric Medical Systems Information Techn | 2002-11-14 |
| H12+HOLTER RECORDER (K021373) | Mortara Instrument, Inc. | 2002-06-27 |
| LIFECARD CF 7 DAY (K011837) | Reynolds Medical , Ltd. | 2001-07-13 |
| CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A (K003707) | Cardionet | 2001-05-16 |
| NEXAN SYSTEM, MODEL NX-300 (K003520) | Nexan, Ltd. | 2000-12-13 |
| CARDIOVISE ECG INTERPRETATIVE SOFTWARE (K001349) | Inovise Medical, Inc. | 2000-07-27 |
| ARIA (K001317) | Del Mar Medical Systems, LLC | 2000-07-21 |
| DR180-II (K001288) | North East Monitoring, Inc. | 2000-07-20 |
| CARDTEL, MODEL NT-100 (K000609) | Cardiac Telecommunications | 2000-05-23 |
| PE 501 PC-ECG MONITOR (K992584) | Nhe Corp. | 2000-01-13 |
| NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 (K993643) | Nexan Telemed , Ltd. | 1999-12-28 |
| DIGITRAKPLUS HOLTER RECORDER (K993617) | Braemar Corp. | 1999-11-24 |
| DXP1000 HOLTER RECORDER (K993618) | Braemar Corp. | 1999-11-24 |
| TES-20 (K992425) | Tes Electrical Electronic Corp. | 1999-10-19 |
| TRACER (K982617) | Heartland Medical Systems, Inc. | 1999-04-09 |
| CMS-2000 (K982843) | Industrial Technology Research Institute | 1998-11-10 |
| DIGITAL ECG HOLTER RECORDER, MODEL DR512 (K982975) | Datrix | 1998-11-10 |