Recorder, Magnetic Tape, Medical
FDA product code DSH · 192 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.2800
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-30 – 2026-07-09
DSH
2026-07-09
DSH
2026-04-23
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
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DSH
2025-12-03
VitaloJAK Clinic (Model 7100)
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DSH
2025-08-15
Zio® monitor (DFG0001)
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DSH
2025-05-05
AeviceMD
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DSH
2025-05-02
AT-Patch (ATP-C130/ATP-C70)
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DSH
2024-09-20
HiCardi+ H100
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DSH
2024-02-16
S-Patch (S-Patch ExL)
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DSH
2023-11-27
ABPMpro
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DSH
2023-11-22
Carnation Ambulatory Monitor
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DSH
2023-09-25
Holter ECG and ABP System
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DSH
2023-08-30
S-Patch Ex Wearable ECG Patch
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DSH
2023-07-07
AeviceMD
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DSH
2023-03-22
CardioSTAT® ECG Test Solution
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DSH
2022-10-20
eWave Monitor
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DSH
2022-10-12
AT-Patch ECG Analysis System
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DSH
2022-08-02
QOCA Portable ECG Monitoring Device
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DSH
2022-04-27
Strados Remote Electronic Stethoscope Platform (RESP)
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DSH
2021-07-20
LifeLens Wireless ECG Monitor
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DSH
2021-05-21
Zio Monitor
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DSH
2021-02-28
QardioCore
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DSH
2021-02-05
Carnation Ambulatory Monitor (CAM)
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DSH
2020-12-29
M5 Recorder
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DSH
2020-12-20
Strados Remote Electronic Stethoscope Platform (RESP)
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DSH
2020-07-29
Bioflux Software II
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DSH
2020-05-01
Carnation Ambulatory Monitor
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DSH
2019-10-17
Carnation Ambulatory Monitor
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DSH
2019-08-30
Carnation Ambulatory Monitor
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DSH
2019-05-16
Carnation Ambulatory Monitor
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DSH
2018-08-03
ECG recorder and Arrhythmia Detector
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DSH
2018-07-24
Portable ECG Monitor (ECG3)
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DSH
2018-01-04
ePatch
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DSH
2017-09-27
Peerbridge Cor(TM) System
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DSH
2017-03-24
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
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DSH
2017-02-22
my Patch sl
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DSH
2016-10-13
Bioflux Software
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DSH
2016-07-15
myPatch-s
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DSH
2013-10-29
MYPATCH
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DSH
2013-05-29
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
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DSH
2012-07-18
ZIO PATCH
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DSH
2012-02-06
ZIO PATCH
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DSH
2011-12-21
MYSENSE HEART
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DSH
2011-11-23
VITALOGRAPH MODEL 7100 - VITALOJAK
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DSH
2011-10-07
GLOBALCARDIO
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DSH
2011-08-01
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
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DSH
2011-06-28
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
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DSH
2011-06-24
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
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DSH
2010-07-09
PULMOTRACK 5050 WHOLTER, MODEL 5050
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DSH
2010-04-02
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
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DSH
2009-06-10
COR12+
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DSH
2009-05-08
ZIO PATCH, MODEL Z100
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DSH
2009-04-01
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
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DSH
2008-01-10
PC-180 / PRINCE 180 EASY ECG MONITOR
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DSH
2007-04-06
MEDILOGAR4, MEDILOGAR12
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DSH
2006-08-16
DMS 300-7
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DSH
2005-08-24
H12+ HOLTER RECORDER
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DSH
2003-10-31
MODIFICATION TO GLOBALCARDIO
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DSH
2003-07-22
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
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DSH
2002-10-24
CARDIO ID+(RZ153+)
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DSH
2002-09-27
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
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DSH
2002-04-05
KING OF HEARTS EXPRESS + AF MONITOR
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DSH
2002-01-31
GLOBALCARDIO
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DSH
2001-01-25
DR180+OXY
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DSH
2000-04-19
LIFECARD CF COMPACT RECORDER
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DSH
1999-06-11
CARDIOLIGHT
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DSH
1999-02-09
OMNICORDER, MODEL 464
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DSH
1999-01-27
MERCATOR
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DSH
1998-08-25
MICROVIT MT-100
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DSH
1998-02-19
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
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DSH
1998-01-29
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
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DSH
1997-08-20
DM-400 HOLTER ECG CASSETTE RECORDER
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DSH
1997-07-28
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
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DSH
1997-05-05
MEDILOG FD4
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DSH
1997-03-13
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
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DSH
1997-03-07
MODEL 700
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DSH
1996-07-31
NORTHEAST MONITORING DR180
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DSH
1995-10-12
VITALOGRAPH 2110 SOFTWARE INTERFACE
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DSH
1995-08-17
HOLTER PACERCORDER(R)
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DSH
1995-07-14
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
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DSH
1995-06-07
SONICAID MODEL MR-63 AMBULATORY ECG RECORDER
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DSH
1995-05-10
HOLTER SSR DIGICORDER(TM)
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DSH
1995-04-12
BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
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DSH
1995-01-24
DIGITAL HOLTER RECORDER
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DSH
1995-01-18
HEARTPRINT
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DSH
1994-10-20
TRACKER 2/TRACKER 3 HOLTER RECORDER
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DSH
1994-08-05
ALTAIR 6100 CASSETTE RECORDER
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DSH
1994-01-13
SCOLE 300 ECG RECORDER
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DSH
1993-12-03
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
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DSH
1993-11-01
MULTITRAK-PLUS
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DSH
1993-09-09
HRV 4000EM
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DSH
1992-04-06
UNISCAN 24 ECG ROCORDER
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DSH
1992-03-30
GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300
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DSH
1991-10-16
WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM
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DSH
1991-10-16
CARD GUARD, MODELS CG-6000 & CG-7000
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DSH
1991-10-04
SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
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DSH
1991-09-20
GALIX MA-6C HOLTER CASSETTE RECORDER
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DSH
1991-09-20
GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER
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DSH
1991-08-19
MR-5200 FULL DISCLOSURE SYSTEM
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DSH
1991-08-07
PR4
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DSH
1991-07-26
MULTICHANNEL RECORDING SYSTEM
View details →No matching devices.
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