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 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K900541 | LIFE-TEL CELLULAR TRANSCEIVER | Racom, Inc. | 1990-07-13 | Traditional | PDF ↗ |
| K896040 | KING OF HEARTS CDM | Instromedix, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K901591 | ESCORT-LINK (MODEL E3200) | Medical Data Electronics | 1990-05-15 | Traditional | PDF ↗ |
| K895719 | TELEREHAB SYSTEM FOR CARDIAC REHABILITATION | Scottcare Corp. | 1990-03-06 | Traditional | PDF ↗ |
| K896039 | KING OF HEARTS 1200 MONITOR | Instromedix, Inc. | 1990-02-28 | Traditional | PDF ↗ |
| K896002 | CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER | Instromedix, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K894856 | CARDIOPHONE | Euro-American Marketing Group, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K894540 | TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000 | Physio-Control Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K894799 | CARDIOBEEPER MEMORY MONITOR CB 600 SERIES | Survival Technology, Inc. | 1989-10-03 | Traditional | PDF ↗ |
| K894340 | PCI MODEL 2041-A TELEMETRY MONITOR | Accucore, Inc. | 1989-10-02 | Traditional | PDF ↗ |
| K893471 | MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING | Medtronic Vascular | 1989-09-26 | Traditional | PDF ↗ |
| K894277 | M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME | Hewlett-Packard Co. | 1989-09-26 | Traditional | PDF ↗ |
| K892370 | DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM | Bio-Focus, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K894140 | MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER | Medtronic Vascular | 1989-07-27 | Traditional | PDF ↗ |
| K890558 | WELLSHIRE BASELINK | American Executive Technology | 1989-03-09 | Traditional | PDF ↗ |
| K890508 | WELLSHIRE EMLINK MODEL 1000 | American Executive Technology | 1989-03-02 | Traditional | PDF ↗ |
| K890461 | CARDIOBEEPER IV | Survival Technology, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K884142 | OXINET N-7500 PULSE OXIMETRY NETWORK | Nellcor, Inc. | 1988-12-16 | Traditional | PDF ↗ |
| K883843 | CARDIOBEEPER II | Survival Technology, Inc. | 1988-11-09 | Traditional | PDF ↗ |
| K881772 | SENSOCOR(TM) R-TEST 240 XL | Sensormedix, Inc. | 1988-11-09 | Traditional | PDF ↗ |
| K883358 | TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM | Telescan Medical Systems | 1988-10-13 | Traditional | PDF ↗ |
| K880971 | DIGITAL MEDICINE ECG MONITOR AND RECORDER | Digital Medicine Systems | 1988-08-30 | Traditional | PDF ↗ |
| K882119 | TELSTETH TELEMETRIC STETHOSCOPE(TM) | Quantsonics, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K882290 | CARD GUARD, MODEL CG-2000 | Card Guard Scientific Survival , Ltd. | 1988-07-22 | Traditional | PDF ↗ |
| K881986 | ESCORT - PORTABLE PATIENT MONITOR | Medical Data Electronics | 1988-07-12 | Traditional | PDF ↗ |
| K880615 | AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30 | Cardiotechnics, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K880533 | VITEL III CM | Equimed Corp. | 1988-05-13 | Traditional | PDF ↗ |
| K880300 | CARDIOBEEPER(R) III | Survival Technology, Inc. | 1988-05-12 | Traditional | PDF ↗ |
| K880626 | KING OF HEARTS | Instromedix, Inc. | 1988-04-11 | Traditional | PDF ↗ |
| K880283 | PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS | Paceart, Inc. | 1988-03-09 | Traditional | PDF ↗ |
| K874387 | PCI MODEL RS100 TELEMETRY MONITOR | Accucore, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K872869 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) | Labeltape Meditect, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K870652 | MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR | Medtronic Vascular | 1987-05-14 | Traditional | PDF ↗ |
| K870527 | CARDIOTEAM | Cardiac Network, Inc. | 1987-04-20 | Traditional | PDF ↗ |
| K864293 | HEART TRACK | Cardio Telemetric Systems, Inc. | 1987-03-23 | Traditional | PDF ↗ |
| K862668 | HEALTHPHONE(TM) | Carelink | 1986-12-22 | Traditional | PDF ↗ |
| K854013 | TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE | Medrand, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K854369 | WEP 7604 TELEMETRY MONITOR | Nihon Kohden America, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K851623 | MODEL TRC-40 TELEMETRY RECIEVER MODULE | Eaton Medical Group | 1986-01-22 | Traditional | PDF ↗ |
| K853096 | CMS 8000 | Physio-Control Corp. | 1986-01-22 | Traditional | PDF ↗ |
| K851624 | MODEL TT-185 TELEMETRY TRANSMITTER | Eaton Medical Group | 1986-01-14 | Traditional | PDF ↗ |
| K852971 | #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER | Medtronic Vascular | 1985-10-22 | Traditional | PDF ↗ |
| K842435 | MODEL T 101 CLINICAL TRANSMITTER | Biometric Products, Inc. | 1985-05-16 | Traditional | PDF ↗ |
| K851123 | R-1000 ECG RECEIVER | Brentwood Instruments, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K851124 | T-1000 ECG TRANSMITTER | Brentwood Instruments, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K842716 | MDE ESCORT 1000 & MDE ESCOR 2000 | Medical Data Electronics | 1985-02-08 | Traditional | PDF ↗ |
| K844966 | CARDIOBEEPER PROFILE MONITOR | Survival Technology, Inc. | 1985-02-08 | Traditional | PDF ↗ |
| K844391 | NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS | Ams Medical, Inc. | 1985-01-07 | Traditional | PDF ↗ |
| K842370 | PAGE-WRITER INTERPRETIVE CARDIOGRAPH | Hewlett-Packard Co. | 1984-12-07 | Traditional | PDF ↗ |
| K840587 | INSTANT REPLAY | Instromedix, Inc. | 1984-10-26 | Traditional | PDF ↗ |
| K840032 | TELEPHONE RECEIVERS R101 R111 | Biometric Products, Inc. | 1984-10-26 | Traditional | PDF ↗ |
| K834034 | MODEM ACCESSORY FOR EPI CARDIA SYS | Medicomp, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K832951 | MEMORY LOOP TRANSMITTER #121 | Biometric Products, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K831443 | PACELINE PATIENT TRANSMITTER MODEL 324 | Pacesetter Systems | 1983-08-12 | Traditional | PDF ↗ |
| K830903 | CARDIO ARRHYTHMIA TRANSMITTER C.A.T | Cardio Technology , Ltd. | 1983-07-26 | Traditional | PDF ↗ |
| K831092 | PECGASYS REMOTE TRANSMISSION UNIT | Datamedix | 1983-07-19 | Traditional | PDF ↗ |
| K830254 | LIFE LINE | Kb & Assoc. | 1983-05-18 | Traditional | PDF ↗ |
| K830477 | CARDIOMEMO III | Instromedix, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830028 | SIRECUST 456 | Analogic Corp. | 1983-01-21 | Traditional | PDF ↗ |
| K822955 | MODEL 4242 TELE SYST ARRHYTHMIA MONITOR | Medtronic Vascular | 1982-11-01 | Traditional | PDF ↗ |
| K821726 | MODEL 535-02 TRACE-A-PACE TRANSMITTER | Intermedics, Inc. | 1982-07-08 | Traditional | PDF ↗ |
| K820986 | EKG MONITORS, VARIOUS MODELS | Dart Medical Equipment | 1982-04-29 | Traditional | PDF ↗ |
| K820904 | EKG TELEPHONE CONVERTER | Dart Medical Equipment | 1982-04-21 | Traditional | PDF ↗ |
| K820452 | PHONOTRACE 2000 | Lowrance Electronics, Inc. | 1982-04-16 | Traditional | PDF ↗ |
| K820828 | SAMM | Dart Medical Equipment | 1982-04-14 | Traditional | PDF ↗ |
| K820276 | TELESCAN T-30 | Telescan Medical Systems | 1982-02-12 | Traditional | PDF ↗ |
| K812793 | P.E.T. | Hospital Equipment Service | 1982-01-18 | Traditional | PDF ↗ |
| K812755 | MODEL 535-03 TRACE A PACE | Intermedics, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812703 | MODEL 9408 A TELETRACE | Medtronic Vascular | 1981-10-23 | Traditional | PDF ↗ |
| K811464 | MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY | Intermedics, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K811758 | ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR | Powers Medical Systmes | 1981-08-03 | Traditional | PDF ↗ |
| K811512 | TELETRACE TELEPHONE EKG SYSTEM | Medtronic Vascular | 1981-06-30 | Traditional | PDF ↗ |
| K810872 | EEG TELEPHONE RECEIVER MODEL #AFR-J | Telediagnostic Systems, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K810608 | TRANSMITTER & RECEIVERS, TELEPHONE, ELEC | Heart Check Systems, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K802717 | HP MODEL 4710A ECG TRANSMITTER | Hewlett-Packard Co. | 1981-01-22 | Traditional | PDF ↗ |
| K803315 | CRITERION II RHYTHM PROFILE MONITOR | Dart Medical Equipment | 1981-01-22 | Traditional | PDF ↗ |
| K802089 | CARDIOTRAK | Cardiac Pacemakers, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801700 | UNI-RECORD I | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-08-07 | Traditional | PDF ↗ |
| K792359 | MEDTRONIC MODEL 9407 TELETRACE TRANSMITT | Medtronic Vascular | 1979-12-05 | Traditional | PDF ↗ |
| K792246 | MEDTRONIC MODEL 9408 TELETRACE TRANSMIT | Medtronic Vascular | 1979-11-21 | Traditional | PDF ↗ |
| K791778 | MEDTRONIC MODEL 9410 TELETRACE RECEIVER | Medtronic Vascular | 1979-10-02 | Traditional | PDF ↗ |
| K782076 | HT-110 MICROMINI | Health Tech | 1978-12-29 | Traditional | PDF ↗ |
| K782059 | TRANSMITTER, TR-1 ECG | Burdick Corp. | 1978-12-21 | Traditional | PDF ↗ |
| K781986 | TRANSMITTER, MODEL 9406 AND 9401 | Medtronic Vascular | 1978-12-13 | Traditional | PDF ↗ |
| K780158 | TELETRACE TELEPHONE EKG TRANSMITTER | Medtronic Vascular | 1978-03-21 | Traditional | PDF ↗ |
| K772350 | PATIENT ALERT MODEL 555 | Intermedics, Inc. | 1978-03-09 | Traditional | PDF ↗ |
| K772186 | ELECTROCARDIOGRAPH TRANSMITTER, 536 | Intermedics, Inc. | 1978-02-02 | Traditional | PDF ↗ |
| K772178 | PACER MONITOR, PULSE WIDTH | Survival Technology, Inc. | 1977-12-08 | Traditional | PDF ↗ |
| K771648 | COMPUTER ECG TERMINAL | Compumed, Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K770949 | COMPUTER ECG TELE. TRANSMISSION TERMINAL | The Okun Co. | 1977-06-02 | Traditional | PDF ↗ |
| K770264 | PACEGUARD | Cardio Data | 1977-02-16 | Traditional | PDF ↗ |
| K760857 | TR-3 TRANSMITTER | Burdick Corp. | 1977-01-28 | Traditional | PDF ↗ |
| K761318 | 3038 OPTION B-COMPUT. TRANS. TERMINAL | Cambridge Instruments, Inc. | 1977-01-06 | Traditional | PDF ↗ |
| K761073 | POCKET TRANSMITTER (PT-10) | Eldeco | 1976-12-28 | Traditional | PDF ↗ |
| K761066 | ECG MONITOR (TELEPHONE ECG TRANSMITTER) | Physio-Control Corp. | 1976-12-09 | Traditional | PDF ↗ |
| K760563 | ECG MODULATOR | Physio-Control Corp. | 1976-09-10 | Traditional | PDF ↗ |
| K760564 | DEMODULATOR SERIES 1400 | Physio-Control Corp. | 1976-09-10 | Traditional | PDF ↗ |
Product code DXH · Class II · Cardiovascular. Data: openFDA.