FDA Product Code
FDA Product Code DRX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2360
510(k) Clearances — 329 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K875041 | FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE | Labeltape Meditect, Inc. | 1988-01-28 | Traditional | PDF ↗ |
| K874562 | SECURATRODE | Meddev International Corp. | 1988-01-28 | Traditional | PDF ↗ |
| K874421 | PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A | Hewlett-Packard Co. | 1988-01-28 | Traditional | PDF ↗ |
| K874422 | PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D | Hewlett-Packard Co. | 1988-01-28 | Traditional | PDF ↗ |
| K874437 | TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE) | Labeltape Meditect, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K873682 | FERRIS ECG ELECTRODE W/HYDROGEL | Ferris Mfg. Corp. | 1987-12-29 | Traditional | PDF ↗ |
| K874628 | RESUBMITTED STANDARD MICROPORE ECG ELECTRODE | Labeltape Meditect, Inc. | 1987-12-07 | Traditional | PDF ↗ |
| K873442 | ECG ELECTRODE SYSTEM | Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S | 1987-11-23 | Traditional | PDF ↗ |
| K872871 | NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) | Labeltape Meditect, Inc. | 1987-10-16 | Traditional | PDF ↗ |
| K872784 | MACTRODE-II | Marquette Electronics, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K871441 | ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE | Nitto Denko America, Inc. | 1987-08-03 | Traditional | PDF ↗ |
| K871748 | THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE | The Buddy Systems, Inc. | 1987-06-10 | Traditional | PDF ↗ |
| K871668 | BIODAN TYPE COMET ELECTRODE | National Medical Technology | 1987-06-10 | Traditional | PDF ↗ |
| K871325 | BOWEN REUSEABLE/DISPOSABLE ELECTRODE | Bowen & Company, Inc. | 1987-06-08 | Traditional | PDF ↗ |
| K871626 | ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200 | Jason Marketing Co. | 1987-06-05 | Traditional | PDF ↗ |
| K871412 | CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO | Contour Electrodes, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K864260 | APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) | Grandcor Medical Systems | 1987-05-11 | Traditional | PDF ↗ |
| K864690 | ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD | Multi Biosensors, Inc. | 1987-05-06 | Traditional | PDF ↗ |
| K870873 | MD MONITORING/DIAGNOSTIC ELECTRODE | Lectec Corp. | 1987-04-10 | Traditional | PDF ↗ |
| K870834 | TDK ECG ELECTRODE MEL-10 | Tdk Corp. | 1987-03-23 | Traditional | PDF ↗ |
| K865011 | PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER | Labeltape Meditect, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K864586 | S&W ELECTRODE TYPES 888, 844, 988 AND 944 | S & W Medico Teknik | 1987-03-13 | Traditional | PDF ↗ |
| K863674 | TRACETS 2000/ELECTRODES | Lectec Corp. | 1987-03-11 | Traditional | PDF ↗ |
| K864722 | MEDI-TRACE INFANT ELECTRODE | Graphic Controls Corp. | 1987-02-10 | Traditional | PDF ↗ |
| K864868 | MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK | Hewlett-Packard Co. | 1987-01-14 | Traditional | PDF ↗ |
| K863369 | MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES | Tdk Corp. | 1987-01-06 | Traditional | PDF ↗ |
| K863904 | DISPOSABLE ECG MONITORING ELECTRODE | Clinical Data, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K863584 | EM II STRESS TEST ELECTRODE | Electromed Intl., Ltd. | 1986-12-08 | Traditional | PDF ↗ |
| K863540 | EM II DISPOSABLE ELECTRODE | Electromed Intl., Ltd. | 1986-12-08 | Traditional | PDF ↗ |
| K863366 | PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE | Labeltape Meditect, Inc. | 1986-11-21 | Traditional | PDF ↗ |
| K863845 | EM III DISPOSABLE ELECTRODE | Electromed Intl., Ltd. | 1986-11-20 | Traditional | PDF ↗ |
| K862618 | SKINTACT AG ELECTRODES | Leon H. Lang Co. | 1986-09-15 | Traditional | PDF ↗ |
| K862655 | SIGNA II RESTING ECG ELECTRODE | Kone Instruments, Inc. | 1986-08-06 | Traditional | PDF ↗ |
| K861246 | PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD | Conmedcorp | 1986-08-06 | Traditional | PDF ↗ |
| K862765 | EUROMED S-601 | Lectec Corp. | 1986-08-06 | Traditional | PDF ↗ |
| K862746 | EM DIAGNOSTIC ECG ELECTRODE | Electromed Intl., Ltd. | 1986-08-06 | Traditional | PDF ↗ |
| K861099 | GEREONICS BIOPOTENTIAL SKIN ELECTRODES | Gereonics, Inc. | 1986-08-06 | Traditional | PDF ↗ |
| K861158 | S&W TYPE 888 ELECTRODE | National Medical Technology | 1986-07-01 | Traditional | PDF ↗ |
| K854433 | ECG MONITORING/DEFIBRILLATION ELECTRODE | Andover Medical, Inc. | 1986-05-08 | Traditional | PDF ↗ |
| K860827 | EM STRESS ELECTRODE | Electromed Intl., Ltd. | 1986-05-08 | Traditional | PDF ↗ |
| K854757 | 5000 SERIES ECG ELECTRODES | Alternative Design Systems, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K853774 | EM ELECTRODE | Electromed Intl., Ltd. | 1986-04-17 | Traditional | PDF ↗ |
| K853939 | ECG-ELECTRODE(SWAROMED) | D. Swarovski & Co. | 1986-04-11 | Traditional | PDF ↗ |
| K853993 | DOBE (MODIFIED) | Phoenix Medical Technology, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K853705 | BOMED-EEA | Bomed Medical Mfr., Ltd. | 1986-01-13 | Traditional | PDF ↗ |
| K853038 | DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES | Bio-Detek, Inc. | 1986-01-07 | Traditional | PDF ↗ |
| K851522 | DIAGNOSTIC ECG DISPOSABLE ELECTRODE | Sentry Medical Products, Inc. | 1985-10-24 | Traditional | PDF ↗ |
| K851732 | CARBOCONE | Imtech Corp. | 1985-09-16 | Traditional | PDF ↗ |
| K852469 | SAF-D-FIB | Medtronic Andover Medical, Inc. | 1985-09-16 | Traditional | PDF ↗ |
| K852177 | FOAM ECG ELECTRODES | Clinical Data, Inc. | 1985-08-09 | Traditional | PDF ↗ |
| K840445 | SYNKARA | Lectec Corp. | 1985-05-16 | Traditional | PDF ↗ |
| K850130 | PRN ECG ELECTRODE | Consolidated Medical Equipment, Inc. | 1985-04-09 | Traditional | PDF ↗ |
| K850132 | DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC | Consolidated Medical Equipment, Inc. | 1985-04-09 | Traditional | PDF ↗ |
| K841944 | DISPOSABLE ECG ELECTRODE | Bristol Medical Electronics Corp. | 1985-03-01 | Traditional | PDF ↗ |
| K842514 | ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD | Multi Biosensors, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K850085 | DISPOSABLE ECG ELECTRODES EASATRACE | Medical Device Marketing | 1985-02-27 | Traditional | PDF ↗ |
| K844856 | ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON | Bristol Medical Electronics Corp. | 1985-02-20 | Traditional | PDF ↗ |
| K844632 | INFANT LIMB ELECTRODE | Sentry Medical Products, Inc. | 1985-01-14 | Traditional | PDF ↗ |
| K844335 | ELECTROCARDIOGRAPH ELECTRODE | Meditect | 1985-01-02 | Traditional | PDF ↗ |
| K844345 | CONTOUR ELECTRODE | Heuristic Medical Systems, Inc. | 1985-01-02 | Traditional | PDF ↗ |
| K844100 | CANMED 101 | Medtronic Vascular | 1984-12-27 | Traditional | PDF ↗ |
| K844099 | CANMED 102 | Medtronic Vascular | 1984-12-27 | Traditional | PDF ↗ |
| K840646 | CARDIOTRODE | Kholber Corp. | 1984-10-26 | Traditional | PDF ↗ |
| K840465 | Q-MED ELECTRODE | Qmed, Inc. | 1984-06-19 | Traditional | PDF ↗ |
| K832903 | ESOPHOGRAL MULTIPROBE | Vital Signs, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K832429 | CARDIO TRACE ELECTRODE | Poly-Med Splint Co. | 1984-05-09 | Traditional | PDF ↗ |
| K834445 | MEDI-TRACE QUIKSET DX DIAG. ELECT- | Graphic Controls Corp. | 1984-04-01 | Traditional | PDF ↗ |
| K833899 | TDK ECG ELECTRODE MEL-08 | Tdk Corp. | 1984-02-10 | Traditional | PDF ↗ |
| K833695 | ADULT MONITORING ELECTOR@@RODE 9431-300 | Marquette Electronics, Inc. | 1984-01-27 | Traditional | PDF ↗ |
| K832877 | PRE-GELLED DISPOS ELECTRODE | Advance Tech Intl. | 1983-12-22 | Traditional | PDF ↗ |
| K832516 | MAGNATRODE CARDIAC MONITORING ELECTRODE | R2 Corp. | 1983-12-16 | Traditional | PDF ↗ |
| K831977 | C TEC SERIES 9000 E.C.G. ELECTRODE | Speywood Medical, Ltd. | 1983-09-09 | Traditional | PDF ↗ |
| K830655 | QUIK-SILVER RESTING ECG ELECTRODE | Quinton, Inc. | 1983-06-15 | Traditional | PDF ↗ |
| K830362 | INFANT ELECTRODE BELT | Sentry Medical Products, Inc. | 1983-06-03 | Traditional | PDF ↗ |
| K830663 | PENCIL SKIN ABRADER | Ndm Corp. | 1983-04-28 | Traditional | PDF ↗ |
| K822750 | MEDI-TRACE 5' OFFSET ELECTRODE | Graphic Controls Corp. | 1982-11-01 | Traditional | PDF ↗ |
| K822798 | DISPOSABLE ELECTRODE #1900 | Andover Medical, Inc. | 1982-10-15 | Traditional | PDF ↗ |
| K821846 | LDS MONITORING ELECTRODE | Life Design Systems, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K821802 | CENTURION ELECTRODE BELT | Clinical Data, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K821434 | EKG (ECG) ELECTRODES | Dupaco, Inc. | 1982-07-30 | Traditional | PDF ↗ |
| K821535 | VITALINE DISPOSABLE EKG ELECTRODE-LEAD | The Halverstadt Co. | 1982-07-08 | Traditional | PDF ↗ |
| K821757 | QUIK - PREP2 ELECTRODE | Quinton, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K821506 | MEDICOTEST ECG ELECTRODES | Medicotest, Inc. | 1982-06-17 | Traditional | PDF ↗ |
| K821438 | RED DOT MONITORING ELECTRODES #2260/65 | 3M Company | 1982-05-25 | Traditional | PDF ↗ |
| K821137 | MEDITRACE PELLET ELECTRODE | Graphic Controls Corp. | 1982-05-18 | Traditional | PDF ↗ |
| K820122 | PIONEER II BACK PLATE ELECTRODE | Life Science Instrumentation, Inc. | 1982-03-01 | Traditional | PDF ↗ |
| K813176 | GEL ELECTRODE | Dyn-A-Med Products | 1981-12-29 | Traditional | PDF ↗ |
| K813013 | GEL ELECTRODE | Arndt Automation & Assoc. | 1981-11-27 | Traditional | PDF ↗ |
| K812878 | THE NEW 1600 ELECTRODE | Andover Medical, Inc. | 1981-11-02 | Traditional | PDF ↗ |
| K812276 | DISPOSABLE ELECTRODE, #1610 | Andover Medical, Inc. | 1981-09-25 | Traditional | PDF ↗ |
| K810895 | ESOPHAGEAL PILL ELECTRODE | Con Med Equipment, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810563 | QUINTON LTE ELECTRODE | Quinton, Inc. | 1981-03-17 | Traditional | PDF ↗ |
| K803179 | DISPOSABLE ELECTRODE FOR EKG | Midwest Monitoring | 1981-03-11 | Traditional | PDF ↗ |
| K810103 | ADULT ECG ELECTRODE #60-0724 | Aspen Laboratories, Inc. | 1981-01-29 | Traditional | PDF ↗ |
| K810102 | INFANT ECG ELECTRODE #60-1029 | Aspen Laboratories, Inc. | 1981-01-29 | Traditional | PDF ↗ |
| K802576 | EXTERNAL JUGULAR CVP CATHERIZATION KIT | Willson | 1980-11-12 | Traditional | PDF ↗ |
| K801846 | ELECTROCARDIOGRAPH ELECTRODE | Phoenix Glove Co. | 1980-09-09 | Traditional | PDF ↗ |
| K800935 | R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) | R2 Corp. | 1980-05-23 | Traditional | PDF ↗ |
| K800930 | R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. | R2 Corp. | 1980-05-23 | Traditional | PDF ↗ |
| K800201 | ESOPHAGEAL PILL-ELECTRODE | Arzbaecher & Co. | 1980-02-26 | Traditional | PDF ↗ |
Product code DRX · Class II · Cardiovascular. Data: openFDA.