FDA Product Code
FDA Product Code DXH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2920
510(k) Clearances — 297 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001634 | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 | Tz Medical, Inc. | 2000-12-21 | Traditional | PDF ↗ |
| K003220 | PERSONAL ECG TRANSMITTER, MODEL CG-6550 | Card Guard Scientific Survival , Ltd. | 2000-11-08 | Special | PDF ↗ |
| K002310 | CARDIOBEEPER CB12/12, MODEL CB12/12 | Meridian Medical Technologies , Ltd. | 2000-10-25 | Traditional | PDF ↗ |
| K002004 | ZYBIT | Zymed Medical Instrumentation | 2000-09-21 | Traditional | PDF ↗ |
| K001091 | CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 | Next Millennium Software Solutions, Inc. | 2000-08-10 | Traditional | PDF ↗ |
| K000775 | HEART 2005 | Aerotel Medical Systems (1998) , Ltd. | 2000-05-17 | Special | PDF ↗ |
| K000225 | CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 | Card Guard Scientific Survival , Ltd. | 2000-02-11 | Special | PDF ↗ |
| K994009 | CG-2100 ECG TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1999-12-21 | Special | PDF ↗ |
| K993799 | CG-7000DX ECG RECORDER/TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1999-12-10 | Special | PDF ↗ |
| K992696 | ECG MINIMONITOR, MODEL CG-5000 | Card Guard Scientific Survival , Ltd. | 1999-10-07 | Traditional | PDF ↗ |
| K992772 | CARDIOPHONICS 1000 MEMORY MONITOR | Rlt Medical Assoc., Inc. | 1999-09-17 | Special | PDF ↗ |
| K990478 | CARD GUARD, MODEL CG-6550 | Card Guard Scientific Survival , Ltd. | 1999-08-31 | Traditional | PDF ↗ |
| K992164 | TELEMEDICINE 2000 | Card Guard Scientific Survival , Ltd. | 1999-08-30 | Special | PDF ↗ |
| K991211 | EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM | Reynolds Medical , Ltd. | 1999-07-08 | Traditional | PDF ↗ |
| K991307 | TELEMEDICINE 2000 | Card Guard Scientific Survival , Ltd. | 1999-06-14 | Special | PDF ↗ |
| K982034 | E-FAX SYSTEM | Blakbag, Ltd., Division of Coherent Systems | 1999-02-19 | Traditional | PDF ↗ |
| K983626 | KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II | Alaris Medical Systems, Inc. | 1999-02-05 | Abbreviated | PDF ↗ |
| K982090 | PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM | Paceart, Inc. | 1999-01-26 | Traditional | PDF ↗ |
| K982228 | FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 | Tz Medical, Inc. | 1999-01-14 | Traditional | PDF ↗ |
| K983026 | PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 | Card Guard Scientific Survival , Ltd. | 1998-12-02 | Traditional | PDF ↗ |
| K983582 | CARDIOBEEPER CB250 | Merdian Medical Technologies , Ltd. | 1998-11-13 | Traditional | PDF ↗ |
| K981119 | CARDIOPAL MODEL NUMBER PM20 | Medicomp, Inc. | 1998-10-14 | Traditional | PDF ↗ |
| K981394 | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 | Braemar Corp. | 1998-09-28 | Traditional | PDF ↗ |
| K980144 | HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER | Aerotel, Ltd. | 1998-06-16 | Traditional | PDF ↗ |
| K980624 | CARDIOSTATION | Universal Medical, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K973267 | TTM5000 TELEPHONIC EKG MONITOR | Hds Medical, Inc. | 1998-01-29 | Traditional | PDF ↗ |
| K973863 | MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR | Hi-Tronics Designs, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K971696 | SENTINEL RECORDER, MODELS 471/472 | Del Mar Avionics | 1997-12-30 | Traditional | PDF ↗ |
| K971650 | RHYTHMSTAT XL | Data Critical Corp. | 1997-12-04 | Traditional | PDF ↗ |
| K972649 | CARDIOCALL CARDIAC EVENT RECORDER | Reynolds Medical , Ltd. | 1997-12-04 | Traditional | PDF ↗ |
| K973141 | HEART ACCESS PLUS CARDIAC EVENT RECORDER | Paceart, Inc. | 1997-11-12 | Traditional | PDF ↗ |
| K963725 | MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED) | Card Guard , Ltd. | 1997-09-10 | Traditional | PDF ↗ |
| K970305 | PRINTER INTERFACE | Micromedical, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K964836 | CARD GUARD, MODEL CG-7100 | Card Guard Scientific Survival , Ltd. | 1997-07-28 | Traditional | PDF ↗ |
| K964036 | CARDIOMAGIC 2000 SOFTWARE | Instromedix, Inc. | 1997-07-18 | Traditional | PDF ↗ |
| K963904 | P.H.D. - PERSONAL HEART DEVICE MODEL 5258 | Heart Alert, Inc. | 1997-05-15 | Traditional | PDF ↗ |
| K962937 | CARDIO TEAM II | Vision Electronics | 1997-04-10 | Traditional | PDF ↗ |
| K965101 | CARDIOBEEPER CB-12L | Meridian Medical Technologies, Inc. | 1997-03-17 | Traditional | PDF ↗ |
| K963375 | CARDIACMONITOR | Vision Electronics | 1997-02-28 | Traditional | PDF ↗ |
| K964888 | HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II | Tz Medical, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K963811 | CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE | Card Guard Scientific Survival , Ltd. | 1996-12-04 | Traditional | PDF ↗ |
| K954350 | CARD GUARD MODEL CG-6500 | Card Guard Scientific Survival , Ltd. | 1996-09-10 | Traditional | PDF ↗ |
| K960499 | HEARTRAK XL | Universal Medical, Inc. | 1996-08-06 | Traditional | PDF ↗ |
| K953762 | HEART 400 ECG TRANSMITTER | Aerotel, Ltd. | 1996-07-18 | Traditional | PDF ↗ |
| K954163 | RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER | Cardiac Evaluation Center, Inc. | 1996-07-11 | Traditional | PDF ↗ |
| K961362 | AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE | Aerotel, Ltd. | 1996-07-10 | Traditional | PDF ↗ |
| K954495 | PACETRAK PLUS | Universal Medical, Inc. | 1996-04-22 | Traditional | PDF ↗ |
| K955060 | ACCELERATED TRANSMISSION PROTOCOL | Instromedix, Inc. | 1996-04-08 | Traditional | PDF ↗ |
| K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER | Instromedix, Inc. | 1996-01-16 | Traditional | PDF ↗ |
| K952065 | PACEART CARDIOVOICE | Paceart, Inc. | 1996-01-16 | Traditional | PDF ↗ |
| K945476 | HEARTHWATCH III(TM) | Instromedix, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS | Instromedix, Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K944362 | HEARTCARD CARDIAC EVENT MONITOR | Instromedix, Inc. | 1995-09-07 | Traditional | PDF ↗ |
| K941898 | MEMORYTRACE ATM MODEL 4222 | Hi-Tronics Designs, Inc. | 1995-06-26 | Traditional | PDF ↗ |
| K942586 | CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) | Telescan Medical Systems | 1995-05-10 | Traditional | PDF ↗ |
| K943124 | HEARTRAK | Universal Medical, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K943123 | PACETRAK | Universal Medical, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K935909 | CG-1000 PERSONAL ECG TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1995-04-28 | Traditional | PDF ↗ |
| K934975 | TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER | Rlt Medical Assoc., Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K943931 | CARRYALL ENHANCEMENTS | Instromedix, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K943995 | IMD PSD 410 PACEMAKER TRANSMITTER | Integrated Medical Devices, Inc. | 1995-03-07 | Traditional | PDF ↗ |
| K931020 | HEART 1001 | Aerotel, Ltd. | 1995-01-11 | Traditional | PDF ↗ |
| K942704 | CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K935586 | PRINCE | Instromedix, Inc. | 1994-11-08 | Traditional | PDF ↗ |
| K924486 | CARD GUARD, MODEL CG-9000 | Card Guard Scientific Survival , Ltd. | 1994-10-31 | Traditional | PDF ↗ |
| K932046 | LIFE-TELL T.S.S. | Raco Products Co. | 1994-08-29 | Traditional | PDF ↗ |
| K933021 | MODEL T131 MEMORY TRANSMITTER | Biometric Products, Inc. | 1994-06-06 | Traditional | PDF ↗ |
| K926515 | CARD GUARD MODEL CG-8000 | Card Guard Scientific Survival , Ltd. | 1994-03-30 | Traditional | PDF ↗ |
| K930314 | HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE | Aerotel, Ltd. | 1994-03-18 | Traditional | PDF ↗ |
| K932863 | E-FAX REMOTE MONITOR | Coherent Systems, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K933012 | MXT-2 12 LEAD MICRO-TRANSMITTER | Medical Electronic Record Exchange | 1994-03-14 | Traditional | PDF ↗ |
| K931585 | CORFAX CARDIAC DATA TRANSMITTER | Ralin Medical, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K932859 | E-FAX RECEIVER | Coherent Systems, Inc. | 1994-02-24 | Traditional | PDF ↗ |
| K931296 | PACEART CARDIOPHONE | Paceart, Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K925639 | CARDIOMAGIC SOFTWARE | Instromedix, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K924187 | INSTANT MEMORY 2000 | Telescan Medical Systems | 1993-06-16 | Traditional | PDF ↗ |
| K925535 | CARDIOBEEPER(R) CB-IIA | Survival Technology, Inc. | 1993-01-28 | Traditional | PDF ↗ |
| K922783 | ES1700 ECG MODULATOR | Epic Systems, Inc. | 1993-01-07 | Traditional | PDF ↗ |
| K921699 | ES 1500 ECG DEMODULATOR | Epic Systems, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K923930 | ELECTROCARDIOGRAPH TRANSMITTER | Tz Medical, Inc. | 1992-10-21 | Traditional | PDF ↗ |
| K920984 | KING OF HEARTS EXPRESS (E.X.) MONITOR | Instromedix, Inc. | 1992-10-14 | Traditional | PDF ↗ |
| K923493 | LIFE-TEL T.R.S. | Raco Products Co. | 1992-09-23 | Traditional | PDF ↗ |
| K921929 | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) | General Devices | 1992-09-18 | Traditional | PDF ↗ |
| K920765 | EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200 | Electronic Monitoring Devices, Inc. | 1992-07-07 | Traditional | PDF ↗ |
| K922412 | ECG MODULATOR | Maguire Ent., Inc. | 1992-07-06 | Traditional | PDF ↗ |
| K915224 | CARDIOPHONICS MEMORY TRANSMITTER | Rlt Medical Assoc., Inc. | 1992-02-07 | Traditional | PDF ↗ |
| K915769 | MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR | Medtronic Vascular | 1992-01-30 | Traditional | PDF ↗ |
| K915472 | ELECTROCARDIOGRAPH TRANSMITTER | Tz, Inc. | 1992-01-24 | Traditional | PDF ↗ |
| K912281 | ES1600 PARAMEDIC TELEPHONE | Epic Systems, Inc. | 1991-11-19 | Traditional | PDF ↗ |
| K913533 | MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) | Hewlett-Packard Co. | 1991-11-07 | Traditional | PDF ↗ |
| K911308 | CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE | Medical Equipment Designs, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K913400 | MODEL SCR-1000 | Accucore, Inc. | 1991-08-21 | Traditional | PDF ↗ |
| K912084 | MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221 | Medtronic Vascular | 1991-07-30 | Traditional | PDF ↗ |
| K904966 | DATAMED MODEL 401A TRANSRECIEVER | Datamed, Inc. | 1991-07-18 | Traditional | PDF ↗ |
| K912379 | PDT CARRYALL TRANSMITTER, VARIOUS MODELS | Cardiac Pacemakers, Inc. | 1991-06-17 | Traditional | PDF ↗ |
| K910451 | CARD GUARD, MODEL CG-2000A | Medtech Industries, Inc. | 1991-06-10 | Traditional | PDF ↗ |
| K910450 | CARD GUARD-3000 ECG TELEPHONE ADAPTER | Medtech Industries, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K904250 | MODEL 4222 AMBULATORY ECG MONITOR | Byrncrest Global, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K903960 | MODEL 9444 TELETRACE II ECG MONITORING SYSTEM | Medtronic Vascular | 1990-10-09 | Traditional | PDF ↗ |
| K902254 | ESCORT MODEL 400T TELEMETRY ECG MONITOR | Medical Data Electronics | 1990-07-27 | Traditional | PDF ↗ |
Product code DXH · Class II · Cardiovascular. Data: openFDA.