FDA 510(k) Applications for Medical Device Product Code "MWJ"
(Electrocardiograph,Ambulatory(Without Analysis))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222017 | Biotricity | Biotres | 07/28/2022 |
| K211709 | Biotricity | Biotres | 01/19/2022 |
| K993617 | BRAEMAR CORP. | DIGITRAKPLUS HOLTER RECORDER | 11/24/1999 |
| K993618 | BRAEMAR CORP. | DXP1000 HOLTER RECORDER | 11/24/1999 |
| K030856 | BRAEMAR CORP. | ER800 SERIES ECG EVENT RECORDER | 03/28/2003 |
| K130294 | BRAEMAR MANUFACTURING LLC | BRAEMAR CARDIOKEY HOLTER RECORDER | 10/16/2013 |
| K042469 | BRAEMAR, INC. | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER | 10/06/2004 |
| K071733 | BRAEMAR, INC. | DL900 SERIES HOLTER RECORDER | 07/24/2007 |
| K071011 | BRAEMAR, INC. | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER | 04/27/2007 |
| K100310 | BTL INDUSTRIES, INC | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS | 10/13/2010 |
| K100266 | CAMNTECH, LTD | ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 | 04/29/2010 |
| K000609 | CARDIAC TELECOMMUNICATIONS | CARDTEL, MODEL NT-100 | 05/23/2000 |
| K003707 | CARDIONET | CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A | 05/16/2001 |
| K031074 | DATRIX | DIGITAL AMBULATORY ECG (HOLTER) RECORDER | 10/15/2003 |
| K982975 | DATRIX | DIGITAL ECG HOLTER RECORDER, MODEL DR512 | 11/10/1998 |
| K001317 | DEL MAR MEDICAL SYSTEMS, LLC. | ARIA | 07/21/2000 |
| K062959 | DIAGNOSTIC MONITORING SOFTWARE | DMS 300-2, 300-3 AND 300-4 | 10/16/2006 |
| K133014 | DIAGNOSTIC MONITORING SOFTWARE | DMS 300-2W HOLTER ECG RECORDER | 05/19/2014 |
| K032466 | ELA MEDICAL, INC. | SPIDERVIEW | 08/22/2003 |
| K091054 | ET MEDICAL DEVICES SPA | WALK400H | 07/27/2009 |
| K101969 | EXELYS LLC | MH1 MICROHOLTER RECORDER | 02/04/2011 |
| K050731 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM | 05/19/2005 |
| K021470 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | SEER LIGHT COMPACT DIGITAL HOLTER RECORDER | 11/14/2002 |
| K122272 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | CARDIOMEM | 03/28/2013 |
| K051686 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | CARDIOMEM CM 3000-12 | 07/14/2005 |
| K063042 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | CARDIOMEM CM 3000-12BT | 05/30/2007 |
| K130785 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | SEER 1000 | 07/26/2013 |
| K982617 | HEARTLAND MEDICAL SYSTEMS, INC. | TRACER | 04/09/1999 |
| K982843 | INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE | CMS-2000 | 11/10/1998 |
| K073545 | INOVISE MEDICAL, INC. | AUDICOR, HEMO AMBULATORY MONITOR | 09/09/2008 |
| K001349 | INOVISE MEDICAL, INC. | CARDIOVISE ECG INTERPRETATIVE SOFTWARE | 07/27/2000 |
| K112601 | INTRICON DATRIX CORPORATION | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | 11/09/2011 |
| K210758 | Medicalgorithmics S.A. | Q Patch | 06/02/2022 |
| K102723 | MEMTEC CORP. | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | 12/09/2010 |
| K071085 | MICRO-STAR INTERNATIONAL CO., LTD. | E3-80 PORTABLE ECG RECORDER & ANALYZER | 10/03/2007 |
| K152626 | MORTARA INSTRUMENT, INC | H3+ Holter Recorder | 02/26/2016 |
| K021373 | MORTARA INSTRUMENT, INC. | H12+HOLTER RECORDER | 06/27/2002 |
| K043010 | MORTARA INSTRUMENT, INC. | HOLTER RECORDER H3+ | 02/25/2005 |
| K003520 | NEXAN LTD | NEXAN SYSTEM, MODEL NX-300 | 12/13/2000 |
| K993643 | NEXAN TELEMED LTD. | NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 | 12/28/1999 |
| K992584 | NHE CORP. | PE 501 PC-ECG MONITOR | 01/13/2000 |
| K161062 | Norav Medical GmbH | NR Recorder | 06/13/2016 |
| K142424 | NORTH EAST MONITORING INC. | DR300 HOLTER MONITOR | 11/25/2014 |
| K070014 | NORTHEAST MONITORING, INC. | AUTO DETECT FOR TELAHEART DR200/E-A | 05/25/2007 |
| K001288 | NORTHEAST MONITORING, INC. | DR180-II | 07/20/2000 |
| K041901 | NORTHEAST MONITORING, INC. | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | 08/31/2004 |
| K061293 | NORTHEAST MONITORING, INC. | TELAHEART DIGITAL RECORDER | 08/25/2006 |
| K112573 | PLATINUM TEAM CO., LTD | EZSLEEP SLEEP QUALITY RECORDER | 03/22/2012 |
| K032882 | RECOM MANAGED SYSTEMS, INC. | RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 | 01/28/2004 |
| K032276 | REMCO ITALIA S.P.A. | CLICK HOLTER | 08/27/2003 |
| K011837 | REYNOLDS MEDICAL LTD. | LIFECARD CF 7 DAY | 07/13/2001 |
| K083382 | SCOTTCARE CORPORATION | CHROMA, MODEL: RZ153C | 08/13/2009 |
| K173156 | Sensydia, Inc. | Integrated CardioRespiratory System | 06/08/2018 |
| K212317 | Spacelabs Healthcare Ltd. | Eclipse MINI Model 98900 | 11/07/2022 |
| K211651 | Spacelabs Healthcare Ltd. | Eclipse PRO | 11/22/2021 |
| K101024 | SUZUKEN CO., LTD. | KENZ CARDY302 MAX | 01/06/2011 |
| K992425 | TES ELECTRICAL ELECTRONIC CORP. | TES-20 | 10/19/1999 |
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