FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K223382 |
Aevice Health Pte. Ltd. |
AeviceMD |
07/07/2023 |
K971604 |
ALEXANDER MFG. CO. |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP |
07/28/1997 |
K172862 |
Andon Health Co., Ltd. |
Portable ECG Monitor (ECG3) |
07/24/2018 |
K203638 |
ATsens Co., Ltd |
AT-Patch ECG Analysis System |
10/12/2022 |
K191000 |
Bardy Diagnostics, Inc |
Carnation Ambulatory Monitor |
05/16/2019 |
K191471 |
Bardy Diagnostics, Inc |
Carnation Ambulatory Monitor |
08/30/2019 |
K192556 |
Bardy Diagnostics, Inc |
Carnation Ambulatory Monitor |
10/17/2019 |
K200870 |
Bardy Diagnostics, Inc |
Carnation Ambulatory Monitor |
05/01/2020 |
K143067 |
BARDY DIAGNOSTICS, INC. |
Carnation Ambulatory Monitor |
12/22/2014 |
K210036 |
Bardy Diagnostics, Inc. |
Carnation Ambulatory Monitor (CAM) |
02/05/2021 |
K201040 |
Biotricity |
Bioflux Software II |
07/29/2020 |
K162571 |
Biotricity Inc. |
Bioflux Software |
10/13/2016 |
K171410 |
Braemar Manufacturing, LLC |
ePatch |
01/04/2018 |
K982448 |
CAPINTEC, INC. |
CARDIOLIGHT |
06/11/1999 |
K020825 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
KING OF HEARTS EXPRESS + AF MONITOR |
04/05/2002 |
K111745 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER |
08/01/2011 |
K130288 |
CARDIAC INSIGHT, INC. |
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE |
05/29/2013 |
K142468 |
CARDIAC INSIGHT, INC. |
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System |
07/11/2015 |
K162503 |
Cardiac Insight, Inc. |
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software |
03/24/2017 |
K113176 |
CARDIAC SCIENCE CORPORATION |
MYSENSE HEART |
12/21/2011 |
K022297 |
CARDIOCOMM SOLUTIONS, INC. |
GLOBAL ECG MANAGEMENT SYSTEM (GEMS) |
09/27/2002 |
K013354 |
CARDIOCOMM SOLUTIONS, INC. |
GLOBALCARDIO |
01/31/2002 |
K111320 |
CARDIOCOMM SOLUTIONS, INC. |
GLOBALCARDIO |
10/07/2011 |
K033037 |
CARDIOCOMM SOLUTIONS, INC. |
MODIFICATION TO GLOBALCARDIO |
10/31/2003 |
K963174 |
DEL MAR AVIONICS |
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) |
03/13/1997 |
K990027 |
DEL MAR AVIONICS |
OMNICORDER, MODEL 464 |
02/09/1999 |
K970298 |
DIAGNOSTIC MONITORING |
DM-400 HOLTER ECG CASSETTE RECORDER |
08/20/1997 |
K062007 |
DIAGNOSTIC MONITORING SOFTWARE |
DMS 300-7 |
08/16/2006 |
K163535 |
DMS-SERVICE LLC |
my Patch sl |
02/22/2017 |
K131190 |
DMS-SERVICE LLC |
MYPATCH |
10/29/2013 |
K160704 |
DMS-SERVICE LLC |
myPatch-s |
07/15/2016 |
K230184 |
Edan Instruments, Inc. |
Holter ECG and ABP System |
09/25/2023 |
K971670 |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER |
01/29/1998 |
K202456 |
Global Instrumentation LLC |
M5 Recorder |
12/29/2020 |
K982384 |
HARLEY STREET SOFTWARE LTD. |
MERCATOR |
01/27/1999 |
K974420 |
HEWLETT-PACKARD CO. |
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION |
02/19/1998 |
K223049 |
Icentia Inc. |
CardioSTAT« ECG Test Solution |
03/22/2023 |
K202359 |
iRhythm Technologies, Inc. |
Zio Monitor |
05/21/2021 |
K113862 |
IRHYTHM TECHNOLOGIES, INC. |
ZIO PATCH |
02/06/2012 |
K121319 |
IRHYTHM TECHNOLOGIES, INC. |
ZIO PATCH |
07/18/2012 |
K090363 |
IRHYTHM TECHNOLOGIES, INC. |
ZIO PATCH, MODEL Z100 |
05/08/2009 |
K143513 |
iRhythm Technologies, Inc. |
ZIO SR ECG Monitoring Service |
06/19/2015 |
K101022 |
KARMELSONIX |
PULMOTRACK 5050 WHOLTER, MODEL 5050 |
07/09/2010 |
K203168 |
LifeLens Technologies, Inc. |
LifeLens Wireless ECG Monitor |
07/20/2021 |
K944180 |
MEMTEC CORP. |
MODEL 700 |
03/07/1997 |
K050896 |
MORTARA INSTRUMENT, INC. |
H12+ HOLTER RECORDER |
08/24/2005 |
K004007 |
NORTHEAST MONITORING, INC. |
DR180+OXY |
01/25/2001 |
K960925 |
NORTHEAST MONITORING, INC. |
NORTHEAST MONITORING DR180 |
07/31/1996 |
K970902 |
OXFORD INSTRUMENTS MEDICAL SYSTEMS |
MEDILOG FD4 |
05/05/1997 |
K171936 |
Peerbridge Health INc. |
Peerbridge Cor(TM) System |
09/27/2017 |
K032103 |
PHILIPS MEDICAL SYSTEMS |
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A |
07/22/2003 |
K201644 |
Qardio Inc. |
QardioCore |
02/28/2021 |
K210179 |
Quanta Computer Inc. |
QOCA Portable ECG Monitoring Device |
08/02/2022 |
K001025 |
REYNOLDS MEDICAL LTD. |
LIFECARD CF COMPACT RECORDER |
04/19/2000 |
K022540 |
ROZINN ELECTRONICS, INC. |
CARDIO ID+(RZ153+) |
10/24/2002 |
K973735 |
SCHILLER AMERICA, INC. |
MICROVIT MT-100 |
08/25/1998 |
K073152 |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
PC-180 / PRINCE 180 EASY ECG MONITOR |
01/10/2008 |
K173461 |
Smart Solutions Technologies SL |
ECG recorder and Arrhythmia Detector |
08/03/2018 |
K201077 |
Strados Labs |
Strados Remote Electronic Stethoscope Platform (RESP) |
12/20/2020 |
K220893 |
Strados Labs, Inc. |
Strados Remote Electronic Stethoscope Platform (RESP) |
04/27/2022 |
K070818 |
TOM MEDICAL ENTWICKLUNGS GMBH |
MEDILOGAR4, MEDILOGAR12 |
04/06/2007 |
K092785 |
VASOMEDICAL, INC. |
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 |
04/02/2010 |
K083820 |
VASOMEDICAL, INC. |
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C |
04/01/2009 |
K111180 |
VASOMEDICAL, INC. |
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY |
06/28/2011 |
K111096 |
VASOMEDICAL, INC. |
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY |
06/24/2011 |
K091505 |
VIASYS HEALTHCARE GMBH |
COR12+ |
06/10/2009 |
K110525 |
VITALOGRAPH(IRELAND) LTD. |
VITALOGRAPH MODEL 7100 - VITALOJAK |
11/23/2011 |
K214073 |
WearLinq, Inc. |
eWave Monitor |
10/20/2022 |
K231289 |
Wellysis Corp. |
S-Patch Ex Wearable ECG Patch |
08/30/2023 |