FDA 510(k) Applications for Medical Device Product Code "DSH"
(Recorder, Magnetic Tape, Medical)

FDA 510(k) Number Applicant Device Name Decision Date
K902766 ADVANCED ISCHEMIA RECORDERS, INC. ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE 03/12/1991
K872508 ADVANCED MEDICAL PRODUCTS, INC. MODEL MICRO FD+ AMBULATORY ECG MONITOR 09/25/1987
K870537 ADVANCED MEDICAL PRODUCTS, INC. MODEL MICRO ST AMBULATORY ECG MONITOR 04/23/1987
K874571 ADVANCED MEDICAL TECHNOLOGY, INC. PATIENTWATCH (TM) 01/29/1988
K833349 AEQUITRON MEDICAL, INC. EVENT TAPE RECORDER 8293 04/17/1984
K901251 AEQUITRON MEDICAL, INC. MODEL 9101 RECORDER/ANALYZER SYSTEM 05/22/1990
K833348 AEQUITRON MEDICAL, INC. RESPIRATION/8100-HEART RATE RECORDER 04/17/1984
K942781 AGILENT TECHNOLOGIES DIGITAL HOLTER RECORDER 01/24/1995
K822970 AGILENT TECHNOLOGIES HOLTER RECORDER 11/03/1982
K971604 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP 07/28/1997
K932929 ALL-TRONICS MEDICAL SYSTEMS HRV 4000EM 09/09/1993
K803222 AMERICAN EDWARDS LABORATORIES ADVANCEMED CCU DOCUMENTOR 01/13/1981
K803224 AMERICAN EDWARDS LABORATORIES ADVANCEMED HOLTER RECORDERS 01/13/1981
K811253 AMERICAN EDWARDS LABORATORIES CASSETTE READER 07/10/1981
K172862 Andon Health Co., Ltd. Portable ECG Monitor (ECG3) 07/24/2018
K823414 ANDOVER MEDICAL, INC. HOLTER KIT MODEL #5000 SERIES 12/30/1982
K813602 APPLIED CARDIAC SYSTEMS HOLTER PERFORMER 01/29/1982
K833823 APPLIED CARDIAC SYSTEMS HOLTER PERFORMER FEATHER WEIGHT/CASS 12/01/1983
K771932 APPLIED MEDICAL RESEARCH RECORDER, DINMAP, MODEL 950 11/07/1977
K892067 ASTRO-MED, INC. MT9000 CHART RECORDER 06/05/1989
K143067 BARDY DIAGNOSTICS, INC. Carnation Ambulatory Monitor 12/22/2014
K841472 BIOGENIX, INC. CARDIORHYTHM 2000 10/29/1984
K912427 BIONIQUE MULTICHANNEL RECORDING SYSTEM 07/26/1991
K162571 Biotricity Inc. Bioflux Software 10/13/2016
K821453 BIRTCHER CORP. CARDIOCASSETTE II #363 05/25/1982
K945130 BRAEMAR CORP. BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER 04/12/1995
K171410 Braemar Manufacturing, LLC ePatch 01/04/2018
K830907 BRENTWOOD INSTRUMENTS, INC. AMBULATORY ECG EVENT RECORDER 07/28/1983
K882366 BRENTWOOD INSTRUMENTS, INC. RHYTHMSCAN HR HOLTER RECORDER 08/02/1988
K870578 BUCKMAN CO., INC. NIGHTWATCH(TM) SYSTEM 06/29/1987
K801001 BURDICK CORP. AMBULATORY MONITOR AM-1 05/28/1980
K942438 BURDICK, INC. ALTAIR 6100 CASSETTE RECORDER 08/05/1994
K790509 CAMBRIDGE INSTRUMENTS, INC. CARDIOCASSETTE II, AMBULATORY ECG SYSTEM 03/23/1979
K895961 CAMBRIDGE MEDICAL INSTRUMENTS, INC. MODEL MC6500 ELECTROCARDIOGRAPH 01/04/1990
K982448 CAPINTEC, INC. CARDIOLIGHT 06/11/1999
K910884 CARD GUARD SCIENTIFIC SURVIVAL, LTD. CARD GUARD, MODELS CG-6000 & CG-7000 10/16/1991
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
K831184 CARDIO DATA CARDIO DATA PACEMAKER RECORDER 05/09/1983
K853262 CARDIO DATA CARDIO DATA PACERECORDER PR3 10/11/1985
K834257 CARDIO DATA CARDIODATA PACE RECORDER 01/30/1984
K831262 CARDIO-SCAN OF TEXAS DATA IV AMBULATORY MONITOR 05/25/1983
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
K873337 CARDIODATA CORP. MODEL SSR1 HOLTER MONITOR 10/09/1987
K772027 CARDIODYNE, INC. CARDIOCASSETTE II 11/09/1977
K862776 CARDIONICS, INC. SPECTRUM POLYCORD I RECORDER SYSTEM 08/18/1986
K842954 CARDIONOSTICS, INC. CARDIONOSTICS HOLTER DURA-LITE RECORDE 09/04/1984
K863863 CARDIONOSTICS, INC. CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE) 10/15/1986
K902486 CARDIONOSTICS, INC. CARDIOVISTA 08/23/1990
K844977 CARDIONOSTICS, INC. HOLTER CURA-LITE RECORDER 01/14/1985
K800214 CIRCADIAN, INC. CIRCAMED I 02/29/1980
K810698 CIRCADIAN, INC. PHARMALOG 04/10/1981
K842349 CLINICAL DATA INSTRUMENTS, INC. AMBULATORY PH RECORDING DEVICE 06/14/1985
K921068 DATRIX GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 03/30/1992
K841654 DEL MAR AVIONICS DEL MAR AVIONICS 509 NEUROCORDER AMBUL 12/11/1984
K833661 DEL MAR AVIONICS ELECTROCARDIOCORDER RECORDER 453 11/28/1983
K963174 DEL MAR AVIONICS HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) 03/13/1997
K950020 DEL MAR AVIONICS HOLTER PACERCORDER(R) 08/17/1995
K942653 DEL MAR AVIONICS HOLTER SSR DIGICORDER(TM) 05/10/1995
K895793 DEL MAR AVIONICS MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION 02/13/1990
K792079 DEL MAR AVIONICS MODEL 447 ELECTROCARDIOCORDER 12/27/1979
K792076 DEL MAR AVIONICS MODEL 448 PACERCORDER 12/27/1979
K792078 DEL MAR AVIONICS MODEL 449 ELECTROCARDIOCORDER 12/27/1979
K884009 DEL MAR AVIONICS MODEL 459 ELECTROCARDIOCORDER RECORDER 11/09/1988
K884330 DEL MAR AVIONICS MODEL 463 ELECTROCARDIORECORDER RECORDER 01/05/1989
K874313 DEL MAR AVIONICS MODEL 492 SSR (TM) RECORDER 02/22/1988
K854269 DEL MAR AVIONICS MODEL 509A PHYSIOCORDER AMBULATORY RECORDER 04/11/1986
K801832 DEL MAR AVIONICS MODEL 9200 VIS-U-SCAN 08/27/1980
K990027 DEL MAR AVIONICS OMNICORDER, MODEL 464 02/09/1999
K871045 DIAGNOSTIC MEDICAL INSTRUMENTS DMI AMBULATORY HOLTER MONITOR 05/19/1987
K830489 DIAGNOSTIC MEDICAL INSTRUMENTS RECORDER DMI 05/25/1983
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
K892227 EDENTEC CORP. EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) 06/20/1989
K761074 ELDECO DYNAMIC RECORDER (DR-10) 12/28/1976
K872229 EQUIMED CORP. VITEL III, ECG TRANSMITTER 07/29/1987
K871944 FUTURECARE SYSTEMS, INC. FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) 06/24/1987
K971670 GALIX BIOMEDICAL INSTRUMENTATION, INC. 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER 01/29/1998
K904177 GALIX INSTRUMENTACION BIOMEDICA GALIX MA-6C HOLTER CASSETTE RECORDER 09/20/1991
K904176 GALIX INSTRUMENTACION BIOMEDICA GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER 09/20/1991
K896153 GENERAL DEVICES MODIFIED DR-2C/PMC 100 01/19/1990
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
K832395 HOLTA-MED HOLTA-MED RECORDER 10/20/1983
K862526 HOLTER RECORDERS MINI-HOLTER, MODEL 2000 08/25/1986
K812763 HOSPITAL EQUIPMENT SERVICE ECG MEDATAPE-601 10/20/1981
K781843 HOVIK CORP. RECORDER, HOLTER ELECTROCARDIOGRAM 11/03/1978
K812920 INSTRUMENTS FOR CARDIAC RESEARCH EVENT MASTER 12/02/1981
K790476 INTL. MEDICAL, INC. QUICKSCAN HOLTER II 06/01/1979
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
K822818 MARQUETTE ELECTRONICS, INC. HOLTER RECORDER & PLAYBACK/ANALYSIS SYS 12/30/1982
K942862 MEDATA, INC. HEARTPRINT 01/18/1995
K760508 MEDCRAFT CORP. ACCUTAPE 24 08/30/1976
K802564 MEDICAL CONCEPTS, INC. MEDICAL MAGNETIC TAPE RECORDER 11/12/1980
K872246 MEDTRONIC VASCULAR MODIFIED MODEL 9431 TELETRACE TRANSMITTER 07/21/1987
K944180 MEMTEC CORP. MODEL 700 03/07/1997
K911257 MENNEN MEDICAL, INC. MR-5200 FULL DISCLOSURE SYSTEM 08/19/1991
K050896 MORTARA INSTRUMENT, INC. H12+ HOLTER RECORDER 08/24/2005
K911097 MORTARA INSTRUMENT, INC. PR4 08/07/1991
K853985 MOUNTAIN VIEW MEDICAL MVM 4000 HOLTER IV RECORDER 11/06/1985
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
K943862 OXFORD INSTRUMENTS MEDICAL SYSTEMS SONICAID MODEL MR-63 AMBULATORY ECG RECORDER 06/07/1995
K890647 OXFORD MEDILOG, INC. MEDILOG 9000-II AMBULATORY RECORDER 03/15/1989
K860181 OXFORD MEDILOG, INC. MODEL MR-30 HOLTER RECORDER 02/26/1986
K860182 OXFORD MEDILOG, INC. MODEL MR-35 HOLTER RECORDER 02/26/1986
K830915 OXFORD MEDILOG, INC. OMAR 07/07/1983
K790289 OXFORD MEDILOG, INC. PB-4 REPLAY UNIT 02/27/1979
K790286 OXFORD MEDILOG, INC. RECORDER, MEDILOG II 02/27/1979
K171936 Peerbridge Health INc. Peerbridge Cor(TM) System 09/27/2017
K851971 PFIZER, INC. SERIES 7000/HOLTER RECORDER 06/20/1985
K032103 PHILIPS MEDICAL SYSTEMS PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A 07/22/2003
K790757 PHYSIO-CONTROL CORP. LIFEPAK 5 MONITOR, CASSETTE, #800923-01 06/01/1979
K893836 QUINTON ELECTROPHYSIOLOGY CORP. EPLAB (ELECTROCARDIOGRAPHIC MONITOR) 09/08/1989
K934660 R & D BATTERIES, INC. R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211 12/03/1993
K890114 RACOM, INC. IMEX RHYTHM TEK 07/27/1989
K913600 RALIN LABORATORIES, INC. WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM 10/16/1991
K870554 RESEARCH INSTRUMENTATION ASSOCIATES, INC. CASSETTE TAPE REPLAY SYSTEM 03/23/1987
K884126 REYNOLDS MEDICAL LTD. E-RAM 10/30/1989
K001025 REYNOLDS MEDICAL LTD. LIFECARD CF COMPACT RECORDER 04/19/2000
K943278 REYNOLDS MEDICAL LTD. TRACKER 2/TRACKER 3 HOLTER RECORDER 10/20/1994
K821516 REYNOLDS MEDICAL LTD. TRACKER-2 CHANNEL ECG TAPE RECORDER 05/28/1982
K022540 ROZINN ELECTRONICS, INC. CARDIO ID+(RZ153+) 10/24/2002
K903331 ROZINN ELECTRONICS, INC. ROZINN 151 10/22/1990
K973735 SCHILLER AMERICA, INC. MICROVIT MT-100 08/25/1998
K822362 SCOLE ENGINEERING CO. ALTA II ECG RECORDER 01/14/1983
K822363 SCOLE ENGINEERING CO. ALTA III ECG RECORDER 10/04/1982
K923664 SCOLE ENGINEERING CO. SCOLE 300 ECG RECORDER 01/13/1994
K073152 SHENZHEN CREATIVE INDUSTRY CO., LTD PC-180 / PRINCE 180 EASY ECG MONITOR 01/10/2008
K841868 SIEMENS MEDICAL SOLUTIONS USA, INC. MINGOGRAF 7 10/24/1984
K173461 Smart Solutions Technologies SL ECG recorder and Arrhythmia Detector 08/03/2018
K913038 SPACELABS, INC. SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION 10/04/1991
K951605 SPACELABS, INC. SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM 07/14/1995
K844940 SPACELABS, INC. SPACELABS MODEL 90201 HOLTER RECORDER 02/14/1985
K820256 SPELNA, INC. MEDILAC #SR4 & SR 40 06/25/1982
K880303 TECHNETICS, INC. POLYCORD II 12/05/1988
K871587 TELESCAN MEDICAL SYSTEMS THE TELESCAN C.A.R.E. SYSTEM 08/12/1987
K070818 TOM MEDICAL ENTWICKLUNGS GMBH MEDILOGAR4, MEDILOGAR12 04/06/2007
K872234 TRANSCOR, INC. TRANSCOR RADIO-STETHOSCOPE MB 08/11/1987
K830519 TRANSMED, INC. CHALLENGER #450 04/12/1983
K920572 UNISCAN LTD. UNISCAN 24 ECG ROCORDER 04/06/1992
K872087 UNITED MEDICAL SUPPLY CO., INC. UMSC HOLTER MONITORING KIT 06/19/1987
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
K863922 VERSAFLEX DELIVERY SYSTEMS, INC. VERSAFLEX(TM) DELTA ST(TM) MONITOR 10/20/1986
K091505 VIASYS HEALTHCARE GMBH COR12+ 06/10/2009
K950854 VITALOGRAPH LTD. VITALOGRAPH 2110 SOFTWARE INTERFACE 10/12/1995
K110525 VITALOGRAPH(IRELAND) LTD. VITALOGRAPH MODEL 7100 - VITALOJAK 11/23/2011
K930894 ZYMED MEDICAL INSTRUMENTATION MULTITRAK-PLUS 11/01/1993


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