FDA Product Code
FDA Product Code MWJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2800
510(k) Clearances — 64 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026-09-11 | Traditional | PDF ↗ |
| K253529 | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | 2026-09-04 | Abbreviated | PDF ↗ |
| K253562 | medilogFD | Schiller AG | 2026-08-14 | Traditional | PDF ↗ |
| K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. | 2026-06-25 | Traditional | PDF ↗ |
| K252839 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | 2026-06-18 | Traditional | PDF ↗ |
| K231424 | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | 2024-12-13 | Traditional | PDF ↗ |
| K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | 2024-05-07 | Traditional | PDF ↗ |
| K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | 2022-11-07 | Traditional | PDF ↗ |
| K222017 | Biotres | Biotricity | 2022-07-28 | Special | PDF ↗ |
| K210758 | Q Patch | Medicalgorithmics S.A. | 2022-06-02 | Traditional | PDF ↗ |
| K211709 | Biotres | Biotricity | 2022-01-19 | Traditional | PDF ↗ |
| K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | 2021-11-22 | Traditional | PDF ↗ |
| K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | 2018-06-08 | Traditional | PDF ↗ |
| K161062 | NR Recorder | Norav Medical GmbH | 2016-06-13 | Traditional | PDF ↗ |
| K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | 2016-02-26 | Traditional | PDF ↗ |
| K142424 | DR300 HOLTER MONITOR | North East Monitoring, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K133014 | DMS 300-2W HOLTER ECG RECORDER | Diagnostic Monitoring Software | 2014-05-19 | Special | PDF ↗ |
| K130294 | BRAEMAR CARDIOKEY HOLTER RECORDER | Braemar Manufacturing, LLC | 2013-10-16 | Special | PDF ↗ |
| K130785 | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | 2013-07-26 | Special | PDF ↗ |
| K122272 | CARDIOMEM | Getemed Medizin- Und Informationstechnik AG | 2013-03-28 | Special | PDF ↗ |
| K112573 | EZSLEEP SLEEP QUALITY RECORDER | Platinum Team Co., Ltd. | 2012-03-22 | Traditional | PDF ↗ |
| K112601 | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | Intricon Datrix Corporation | 2011-11-09 | Traditional | PDF ↗ |
| K101969 | MH1 MICROHOLTER RECORDER | Exelys, LLC | 2011-02-04 | Traditional | PDF ↗ |
| K101024 | KENZ CARDY302 MAX | Suzuken Co., Ltd. | 2011-01-06 | Traditional | PDF ↗ |
| K102723 | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | Memtec Corp. | 2010-12-09 | Traditional | PDF ↗ |
| K100310 | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS | BTL Industries, Inc. | 2010-10-13 | Traditional | PDF ↗ |
| K100266 | ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 | Camntech, Ltd. | 2010-04-29 | Abbreviated | PDF ↗ |
| K083382 | CHROMA, MODEL: RZ153C | Scottcare Corporation | 2009-08-13 | Traditional | PDF ↗ |
| K091054 | WALK400H | Et Medical Devices Spa | 2009-07-27 | Abbreviated | PDF ↗ |
| K073545 | AUDICOR, HEMO AMBULATORY MONITOR | Inovise Medical, Inc. | 2008-09-09 | Traditional | PDF ↗ |
| K071085 | E3-80 PORTABLE ECG RECORDER & ANALYZER | Micro-Star International Co., Ltd. | 2007-10-03 | Traditional | PDF ↗ |
| K071733 | DL900 SERIES HOLTER RECORDER | Braemar, Inc. | 2007-07-24 | Special | PDF ↗ |
| K063042 | CARDIOMEM CM 3000-12BT | Getemed Medizin- Und Informationstechnik AG | 2007-05-30 | Special | PDF ↗ |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | North East Monitoring, Inc. | 2007-05-25 | Traditional | PDF ↗ |
| K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER | Braemar, Inc. | 2007-04-27 | Special | PDF ↗ |
| K062959 | DMS 300-2, 300-3 AND 300-4 | Diagnostic Monitoring Software | 2006-10-16 | Special | PDF ↗ |
| K061293 | TELAHEART DIGITAL RECORDER | North East Monitoring, Inc. | 2006-08-25 | Abbreviated | PDF ↗ |
| K051686 | CARDIOMEM CM 3000-12 | Getemed Medizin- Und Informationstechnik AG | 2005-07-14 | Abbreviated | PDF ↗ |
| K050731 | SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM | Ge Medical Systems Information Technologies | 2005-05-19 | Traditional | PDF ↗ |
| K043010 | HOLTER RECORDER H3+ | Mortara Instrument, Inc. | 2005-02-25 | Abbreviated | PDF ↗ |
| K042469 | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER | Braemar, Inc. | 2004-10-06 | Traditional | PDF ↗ |
| K041901 | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | North East Monitoring, Inc. | 2004-08-31 | Abbreviated | PDF ↗ |
| K032882 | RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 | Recom Managed Systems, Inc. | 2004-01-28 | Abbreviated | PDF ↗ |
| K031074 | DIGITAL AMBULATORY ECG (HOLTER) RECORDER | Datrix | 2003-10-15 | Traditional | PDF ↗ |
| K032276 | CLICK HOLTER | Remco Italia S.P.A. | 2003-08-27 | Abbreviated | PDF ↗ |
| K032466 | SPIDERVIEW | Ela Medical, Inc. | 2003-08-22 | Special | PDF ↗ |
| K030856 | ER800 SERIES ECG EVENT RECORDER | Braemar Corp. | 2003-03-28 | Special | PDF ↗ |
| K021470 | SEER LIGHT COMPACT DIGITAL HOLTER RECORDER | General Electric Medical Systems Information Techn | 2002-11-14 | Traditional | PDF ↗ |
| K021373 | H12+HOLTER RECORDER | Mortara Instrument, Inc. | 2002-06-27 | Special | PDF ↗ |
| K011837 | LIFECARD CF 7 DAY | Reynolds Medical , Ltd. | 2001-07-13 | Special | PDF ↗ |
| K003707 | CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A | Cardionet | 2001-05-16 | Traditional | PDF ↗ |
| K003520 | NEXAN SYSTEM, MODEL NX-300 | Nexan, Ltd. | 2000-12-13 | Special | PDF ↗ |
| K001349 | CARDIOVISE ECG INTERPRETATIVE SOFTWARE | Inovise Medical, Inc. | 2000-07-27 | Traditional | PDF ↗ |
| K001317 | ARIA | Del Mar Medical Systems, LLC | 2000-07-21 | Abbreviated | PDF ↗ |
| K001288 | DR180-II | North East Monitoring, Inc. | 2000-07-20 | Abbreviated | PDF ↗ |
| K000609 | CARDTEL, MODEL NT-100 | Cardiac Telecommunications | 2000-05-23 | Traditional | PDF ↗ |
| K992584 | PE 501 PC-ECG MONITOR | Nhe Corp. | 2000-01-13 | Traditional | PDF ↗ |
| K993643 | NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 | Nexan Telemed , Ltd. | 1999-12-28 | Traditional | PDF ↗ |
| K993617 | DIGITRAKPLUS HOLTER RECORDER | Braemar Corp. | 1999-11-24 | Special | PDF ↗ |
| K993618 | DXP1000 HOLTER RECORDER | Braemar Corp. | 1999-11-24 | Special | PDF ↗ |
| K992425 | TES-20 | Tes Electrical Electronic Corp. | 1999-10-19 | Traditional | PDF ↗ |
| K982617 | TRACER | Heartland Medical Systems, Inc. | 1999-04-09 | Traditional | PDF ↗ |
| K982843 | CMS-2000 | Industrial Technology Research Institute | 1998-11-10 | Traditional | PDF ↗ |
| K982975 | DIGITAL ECG HOLTER RECORDER, MODEL DR512 | Datrix | 1998-11-10 | Traditional | PDF ↗ |
Product code MWJ · Class II · Cardiovascular. Data: openFDA.