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 |