Electrocardiograph, Ambulatory (Without Analysis)
FDA product code MWJ · Class II (moderate risk) · 21 CFR 870.2800 · Cardiovascular
64510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Braemar, Inc. 6
- North East Monitoring, Inc. 5
- Getemed Medizin- Und Informationstechnik AG 4
- Mortara Instrument, Inc. 3
- Inovise Medical, Inc. 2
- Diagnostic Monitoring Software 2
- Spacelabs Healthcare, Llc 2
- Biotricity 2
- Datrix 2
- Shenzhen Xinyan Medical Technology Co.,ltd. 1
- Del Mar Medical Systems, LLC 1
- Industrial Technology Research Institute 1
- Nexan, Ltd. 1
- Cardionet, Inc. 1
- Reynolds Medical , Ltd. 1
- Nhe Corp. 1
- General Electric Medical Systems Information Techn 1
- Nexan Telemed , Ltd. 1
- Remco Italia S.P.A. 1
- Tes Electrical Electronic Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…MWJ · Traditional | Shenzhen Xinyan Medical Technology Co.,ltd. | 09/11/2026SE |
| K253529 | Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated | Peerbridge Health, Inc. | 09/04/2026SE |
| K253562 | medilogFDMWJ · Traditional | Schiller AG | 08/14/2026SE |
| K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…MWJ · Traditional | Seers Technology Co., Ltd. | 06/25/2026SE |
| K252839 | ZywieZ3 Sensor & AdhesiveMWJ · Traditional | Zywie, Inc. | 06/18/2026SE |
| K231424 | HeartBeam AIMIGo(TM) SystemMWJ · Traditional | Heartbeam, Inc. | 12/13/2024SE |
| K233864 | ASSURE Wearable ECGMWJ · Traditional | Kestra Medical Technologies, Inc. | 05/07/2024SE |
| K212317 | Eclipse MINI Model 98900MWJ · Traditional | Spacelabs Healthcare, Ltd. | 11/07/2022SE |
| K222017 | BiotresMWJ · Special | Biotricity | 07/28/2022SE |
| K210758 | Q PatchMWJ · Traditional | Medicalgorithmics S.A. | 06/02/2022SE |
| K211709 | BiotresMWJ · Traditional | Biotricity | 01/19/2022SE |
| K211651 | Eclipse PROMWJ · Traditional | Spacelabs Healthcare, Ltd. | 11/22/2021SE |
| K173156 | Integrated CardioRespiratory SystemMWJ · Traditional | Sensydia, Inc. | 06/08/2018SE |
| K161062 | NR RecorderMWJ · Traditional | Norav Medical GmbH | 06/13/2016SE |
| K152626 | H3+ Holter RecorderMWJ · Traditional | Mortara Instrument, Inc. | 02/26/2016SE |
| K142424 | DR300 Holter MonitorMWJ · Traditional | North East Monitoring, Inc. | 11/25/2014SE |
| K133014 | DMS 300-2W Holter ECG RecorderMWJ · Special | Diagnostic Monitoring Software | 05/19/2014SE |
| K130294 | Braemar Cardiokey Holter RecorderMWJ · Special | Braemar Manufacturing, LLC | 10/16/2013SE |
| K130785 | Seer 1000MWJ · Special | Getemed Medizin- Und Informationstechnik AG | 07/26/2013SE |
| K122272 | CardiomemMWJ · Special | Getemed Medizin- Und Informationstechnik AG | 03/28/2013SE |
| K112573 | Ezsleep Sleep Quality RecorderMWJ · Traditional | Platinum Team Co., Ltd. | 03/22/2012SE |
| K112601 | Intricon Datrix Sirona Event/ Holter RecorderMWJ · Traditional | Intricon Datrix Corporation | 11/09/2011SE |
| K101969 | MH1 Microholter RecorderMWJ · Traditional | Exelys, LLC | 02/04/2011SE |
| K101024 | Kenz CARDY302 MaxMWJ · Traditional | Suzuken Co., Ltd. | 01/06/2011SE |
| K102723 | Model 950-12L Holter Recorder Without AnalysisMWJ · Traditional | Memtec Corp. | 12/09/2010SE |
| K100310 | BTL-08 ECG Recorder Model BTL-08 ECG LC Plus, BTL-08 ECG LT PlusMWJ · Traditional | BTL Industries, Inc. | 10/13/2010SE |
| K100266 | Actiwave 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, Actiwave Cardio Model 08-514, 08-521…MWJ · Abbreviated | Camntech, Ltd. | 04/29/2010SE |
| K083382 | Chroma, Model: RZ153CMWJ · Traditional | Scottcare Corporation | 08/13/2009SE |
| K091054 | WALK400HMWJ · Abbreviated | Et Medical Devices Spa | 07/27/2009SE |
| K073545 | Audicor, Hemo Ambulatory MonitorMWJ · Traditional | Inovise Medical, Inc. | 09/09/2008SE |
| K071085 | E3-80 Portable ECG Recorder & AnalyzerMWJ · Traditional | Micro-Star International Co., Ltd. | 10/03/2007SE |
| K071733 | DL900 Series Holter RecorderMWJ · Special | Braemar, Inc. | 07/24/2007SE |
| K063042 | Cardiomem CM 3000-12BTMWJ · Special | Getemed Medizin- Und Informationstechnik AG | 05/30/2007SE |
| K070014 | Auto Detect for Telaheart DR200/E-AMWJ · Traditional | North East Monitoring, Inc. | 05/25/2007SE |
| K071011 | Modification to: Braemar ER900 Series Enhanced Algorithm ECG Event RecorderMWJ · Special | Braemar, Inc. | 04/27/2007SE |
| K062959 | DMS 300-2, 300-3 and 300-4MWJ · Special | Diagnostic Monitoring Software | 10/16/2006SE |
| K061293 | Telaheart Digital RecorderMWJ · Abbreviated | North East Monitoring, Inc. | 08/25/2006SE |
| K051686 | Cardiomem CM 3000-12MWJ · Abbreviated | Getemed Medizin- Und Informationstechnik AG | 07/14/2005SE |
| K050731 | Seer Light Extend Compact Digital Holter SystemMWJ · Traditional | Ge Medical Systems Information Technologies | 05/19/2005SE |
| K043010 | Holter Recorder H3+MWJ · Abbreviated | Mortara Instrument, Inc. | 02/25/2005SE |
| K042469 | Braemar ER800 Series Enhanced Algorithm Event RecorderMWJ · Traditional | Braemar, Inc. | 10/06/2004SE |
| K041901 | SD360 Digital RECORDER/SD360 Holter Digital RecorderMWJ · Abbreviated | North East Monitoring, Inc. | 08/31/2004SE |
| K032882 | Recom Battery-Operated Ambulatory Digital Wireless ECG Monitor, Model 100MWJ · Abbreviated | Recom Managed Systems, Inc. | 01/28/2004SE |
| K031074 | Digital Ambulatory ECG (Holter) RecorderMWJ · Traditional | Datrix | 10/15/2003SE |
| K032276 | Click HolterMWJ · Abbreviated | Remco Italia S.P.A. | 08/27/2003SE |
| K032466 | SpiderviewMWJ · Special | Ela Medical, Inc. | 08/22/2003SE |
| K030856 | ER800 Series ECG Event RecorderMWJ · Special | Braemar Corp. | 03/28/2003SE |
| K021470 | Seer Light Compact Digital Holter RecorderMWJ · Traditional | General Electric Medical Systems Information Techn | 11/14/2002SE |
| K021373 | H12+HOLTER RecorderMWJ · Special | Mortara Instrument, Inc. | 06/27/2002SE |
| K011837 | Lifecard CF 7 DayMWJ · Special | Reynolds Medical , Ltd. | 07/13/2001SE |
| K003707 | Cardionet Ambulatory ECG Monitor, Model CN1000AMWJ · Traditional | Cardionet | 05/16/2001SE |
| K003520 | Nexan System, Model NX-300MWJ · Special | Nexan, Ltd. | 12/13/2000SE |
| K001349 | Cardiovise ECG Interpretative SoftwareMWJ · Traditional | Inovise Medical, Inc. | 07/27/2000SE |
| K001317 | AriaMWJ · Abbreviated | Del Mar Medical Systems, LLC | 07/21/2000SE |
| K001288 | DR180-IIMWJ · Abbreviated | North East Monitoring, Inc. | 07/20/2000SE |
| K000609 | Cardtel, Model NT-100MWJ · Traditional | Cardiac Telecommunications | 05/23/2000SE |
| K992584 | Pe 501 Pc-Ecg MonitorMWJ · Traditional | Nhe Corp. | 01/13/2000SE |
| K993643 | Nexsystem Ambulatory Patient Monitor Model Nex 100MWJ · Traditional | Nexan Telemed , Ltd. | 12/28/1999SE |
| K993618 | DXP1000 Holter RecorderMWJ · Special | Braemar Corp. | 11/24/1999SE |
| K993617 | Digitrakplus Holter RecorderMWJ · Special | Braemar Corp. | 11/24/1999SE |
| K992425 | TES-20MWJ · Traditional | Tes Electrical Electronic Corp. | 10/19/1999SE |
| K982617 | TracerMWJ · Traditional | Heartland Medical Systems, Inc. | 04/09/1999SE |
| K982975 | Digital ECG Holter Recorder, Model DR512MWJ · Traditional | Datrix | 11/10/1998SE |
| K982843 | CMS-2000MWJ · Traditional | Industrial Technology Research Institute | 11/10/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0685-2025 Class II | Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive…Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter… | Spacelabs Healthcare, Ltd. | 11/25/2024Open, Classified |
| Z-0684-2025 Class II | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter…Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter… | Spacelabs Healthcare, Ltd. | 11/25/2024Open, Classified |
| Z-1460-2020 Class II | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150…An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can… | Braemar Manufacturing, LLC | 01/22/2020Terminated |
| Z-1459-2020 Class II | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150…An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can… | Braemar Manufacturing, LLC | 01/22/2020Terminated |
| Z-1345-2020 Class II | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT…if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is… | Philips North America, LLC | 01/13/2020Terminated |