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DXH

297 FDA 510(k) clearances · Product code

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RecordFirmDate
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 (K001634)Tz Medical, Inc.2000-12-21
PERSONAL ECG TRANSMITTER, MODEL CG-6550 (K003220)Card Guard Scientific Survival , Ltd.2000-11-08
CARDIOBEEPER CB12/12, MODEL CB12/12 (K002310)Meridian Medical Technologies , Ltd.2000-10-25
ZYBIT (K002004)Zymed Medical Instrumentation2000-09-21
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 (K001091)Next Millennium Software Solutions, Inc.2000-08-10
HEART 2005 (K000775)Aerotel Medical Systems (1998) , Ltd.2000-05-17
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 (K000225)Card Guard Scientific Survival , Ltd.2000-02-11
CG-2100 ECG TRANSMITTER (K994009)Card Guard Scientific Survival , Ltd.1999-12-21
CG-7000DX ECG RECORDER/TRANSMITTER (K993799)Card Guard Scientific Survival , Ltd.1999-12-10
ECG MINIMONITOR, MODEL CG-5000 (K992696)Card Guard Scientific Survival , Ltd.1999-10-07
CARDIOPHONICS 1000 MEMORY MONITOR (K992772)Rlt Medical Assoc., Inc.1999-09-17
CARD GUARD, MODEL CG-6550 (K990478)Card Guard Scientific Survival , Ltd.1999-08-31
TELEMEDICINE 2000 (K992164)Card Guard Scientific Survival , Ltd.1999-08-30
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM (K991211)Reynolds Medical , Ltd.1999-07-08
TELEMEDICINE 2000 (K991307)Card Guard Scientific Survival , Ltd.1999-06-14
E-FAX SYSTEM (K982034)Blakbag, Ltd., Division of Coherent Systems1999-02-19
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II (K983626)Alaris Medical Systems, Inc.1999-02-05
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM (K982090)Paceart, Inc.1999-01-26
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 (K982228)Tz Medical, Inc.1999-01-14
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 (K983026)Card Guard Scientific Survival , Ltd.1998-12-02
CARDIOBEEPER CB250 (K983582)Merdian Medical Technologies , Ltd.1998-11-13
CARDIOPAL MODEL NUMBER PM20 (K981119)Medicomp, Inc.1998-10-14
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 (K981394)Braemar Corp.1998-09-28
HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER (K980144)Aerotel, Ltd.1998-06-16
CARDIOSTATION (K980624)Universal Medical, Inc.1998-05-11
TTM5000 TELEPHONIC EKG MONITOR (K973267)Hds Medical, Inc.1998-01-29
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR (K973863)Hi-Tronics Designs, Inc.1998-01-02
SENTINEL RECORDER, MODELS 471/472 (K971696)Del Mar Avionics1997-12-30
CARDIOCALL CARDIAC EVENT RECORDER (K972649)Reynolds Medical , Ltd.1997-12-04
RHYTHMSTAT XL (K971650)Data Critical Corp.1997-12-04
HEART ACCESS PLUS CARDIAC EVENT RECORDER (K973141)Paceart, Inc.1997-11-12
MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED) (K963725)Card Guard , Ltd.1997-09-10
PRINTER INTERFACE (K970305)Micromedical, Inc.1997-08-15
CARD GUARD, MODEL CG-7100 (K964836)Card Guard Scientific Survival , Ltd.1997-07-28
CARDIOMAGIC 2000 SOFTWARE (K964036)Instromedix, Inc.1997-07-18
P.H.D. - PERSONAL HEART DEVICE MODEL 5258 (K963904)Heart Alert, Inc.1997-05-15
CARDIO TEAM II (K962937)Vision Electronics1997-04-10
CARDIOBEEPER CB-12L (K965101)Meridian Medical Technologies, Inc.1997-03-17
CARDIACMONITOR (K963375)Vision Electronics1997-02-28
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II (K964888)Tz Medical, Inc.1997-02-28
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (K963811)Card Guard Scientific Survival , Ltd.1996-12-04
CARD GUARD MODEL CG-6500 (K954350)Card Guard Scientific Survival , Ltd.1996-09-10
HEARTRAK XL (K960499)Universal Medical, Inc.1996-08-06
HEART 400 ECG TRANSMITTER (K953762)Aerotel, Ltd.1996-07-18
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER (K954163)Cardiac Evaluation Center, Inc.1996-07-11
AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE (K961362)Aerotel, Ltd.1996-07-10
PACETRAK PLUS (K954495)Universal Medical, Inc.1996-04-22
ACCELERATED TRANSMISSION PROTOCOL (K955060)Instromedix, Inc.1996-04-08
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER (K951096)Instromedix, Inc.1996-01-16
PACEART CARDIOVOICE (K952065)Paceart, Inc.1996-01-16
HEARTHWATCH III(TM) (K945476)Instromedix, Inc.1995-11-09
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS (K950003)Instromedix, Inc.1995-10-31
HEARTCARD CARDIAC EVENT MONITOR (K944362)Instromedix, Inc.1995-09-07
MEMORYTRACE ATM MODEL 4222 (K941898)Hi-Tronics Designs, Inc.1995-06-26
CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) (K942586)Telescan Medical Systems1995-05-10
PACETRAK (K943123)Universal Medical, Inc.1995-05-03
HEARTRAK (K943124)Universal Medical, Inc.1995-05-03
CG-1000 PERSONAL ECG TRANSMITTER (K935909)Card Guard Scientific Survival , Ltd.1995-04-28
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER (K934975)Rlt Medical Assoc., Inc.1995-04-06
CARRYALL ENHANCEMENTS (K943931)Instromedix, Inc.1995-04-04
IMD PSD 410 PACEMAKER TRANSMITTER (K943995)Integrated Medical Devices, Inc.1995-03-07
HEART 1001 (K931020)Aerotel, Ltd.1995-01-11
CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER (K942704)Card Guard Scientific Survival , Ltd.1994-12-05
PRINCE (K935586)Instromedix, Inc.1994-11-08
CARD GUARD, MODEL CG-9000 (K924486)Card Guard Scientific Survival , Ltd.1994-10-31
LIFE-TELL T.S.S. (K932046)Raco Products Co.1994-08-29
MODEL T131 MEMORY TRANSMITTER (K933021)Biometric Products, Inc.1994-06-06
CARD GUARD MODEL CG-8000 (K926515)Card Guard Scientific Survival , Ltd.1994-03-30
HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE (K930314)Aerotel, Ltd.1994-03-18
E-FAX REMOTE MONITOR (K932863)Coherent Systems, Inc.1994-03-16
MXT-2 12 LEAD MICRO-TRANSMITTER (K933012)Medical Electronic Record Exchange1994-03-14
CORFAX CARDIAC DATA TRANSMITTER (K931585)Ralin Medical, Inc.1994-03-07
E-FAX RECEIVER (K932859)Coherent Systems, Inc.1994-02-24
PACEART CARDIOPHONE (K931296)Paceart, Inc.1993-10-01
CARDIOMAGIC SOFTWARE (K925639)Instromedix, Inc.1993-06-22
INSTANT MEMORY 2000 (K924187)Telescan Medical Systems1993-06-16
CARDIOBEEPER(R) CB-IIA (K925535)Survival Technology, Inc.1993-01-28
ES1700 ECG MODULATOR (K922783)Epic Systems, Inc.1993-01-07
ES 1500 ECG DEMODULATOR (K921699)Epic Systems, Inc.1992-12-17
ELECTROCARDIOGRAPH TRANSMITTER (K923930)Tz Medical, Inc.1992-10-21
KING OF HEARTS EXPRESS (E.X.) MONITOR (K920984)Instromedix, Inc.1992-10-14
LIFE-TEL T.R.S. (K923493)Raco Products Co.1992-09-23
GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) (K921929)General Devices1992-09-18
EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200 (K920765)Electronic Monitoring Devices, Inc.1992-07-07
ECG MODULATOR (K922412)Maguire Ent., Inc.1992-07-06
CARDIOPHONICS MEMORY TRANSMITTER (K915224)Rlt Medical Assoc., Inc.1992-02-07
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR (K915769)Medtronic Vascular1992-01-30
ELECTROCARDIOGRAPH TRANSMITTER (K915472)Tz, Inc.1992-01-24
ES1600 PARAMEDIC TELEPHONE (K912281)Epic Systems, Inc.1991-11-19
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) (K913533)Hewlett-Packard Co.1991-11-07
CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE (K911308)Medical Equipment Designs, Inc.1991-09-11
MODEL SCR-1000 (K913400)Accucore, Inc.1991-08-21
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221 (K912084)Medtronic Vascular1991-07-30
DATAMED MODEL 401A TRANSRECIEVER (K904966)Datamed, Inc.1991-07-18
PDT CARRYALL TRANSMITTER, VARIOUS MODELS (K912379)Cardiac Pacemakers, Inc.1991-06-17
CARD GUARD, MODEL CG-2000A (K910451)Medtech Industries, Inc.1991-06-10
CARD GUARD-3000 ECG TELEPHONE ADAPTER (K910450)Medtech Industries, Inc.1991-05-07
MODEL 4222 AMBULATORY ECG MONITOR (K904250)Byrncrest Global, Inc.1991-02-25
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM (K903960)Medtronic Vascular1990-10-09
ESCORT MODEL 400T TELEMETRY ECG MONITOR (K902254)Medical Data Electronics1990-07-27
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