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 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K950477 | DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM | Nikomed U.S.A., Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K950480 | DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM | Nikomed U.S.A., Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K950587 | ECOTABS | Msb , Ltd. | 1995-10-16 | Traditional | PDF ↗ |
| K950479 | DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM | Nikomed U.S.A., Inc. | 1995-09-13 | Traditional | PDF ↗ |
| K950476 | DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM | Nikomed U.S.A., Inc. | 1995-09-06 | Traditional | PDF ↗ |
| K944260 | ECG ELECTRODE | Msb , Ltd. | 1995-07-07 | Traditional | PDF ↗ |
| K945479 | MEDI-TRACE(R) 500 ECG ELECTRODE | Graphic Controls Corp. | 1995-07-07 | Traditional | PDF ↗ |
| K950485 | GRAPHIC CONTROLS PROTRACE ECG ELECTRODE | Graphic Controls Corp. | 1995-07-07 | Traditional | PDF ↗ |
| K950489 | GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE | Graphic Controls Corp. | 1995-07-03 | Traditional | PDF ↗ |
| K950488 | GRAPHIC CONTROLS BIOTAC ECO ELECTRODE | Graphic Controls Corp. | 1995-07-03 | Traditional | PDF ↗ |
| K945836 | 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES | Conmed Andover Medical, Inc. | 1995-06-20 | Traditional | PDF ↗ |
| K946273 | 1700 MONITORING ECG ELECTRODE | Conmed Andover Medical, Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K950486 | GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE | Graphic Controls Corp. | 1995-05-17 | Traditional | PDF ↗ |
| K950487 | GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE | Graphic Controls Corp. | 1995-05-17 | Traditional | PDF ↗ |
| K935437 | ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES | Arbo Medical, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K932903 | EKG VEST | Cardiotronics, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K943301 | QUIK COMBO | Physio-Control Corp. | 1995-02-03 | Traditional | PDF ↗ |
| K935371 | R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD | R2 Medical Systems | 1994-12-02 | Traditional | PDF ↗ |
| K944726 | 1710 MONITORING ECG ELECTRODE | Conmed Andover Medical, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K934505 | TRIGEL MULTIFUNCTION ELECTRODE | Physiometrix, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K944655 | ECG ELECTRODE | Conmed Andover Medical, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K935246 | ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1994-11-16 | Traditional | PDF ↗ |
| K945214 | MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE | Graphic Controls Corp. | 1994-11-10 | Traditional | PDF ↗ |
| K935429 | ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944849 | 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE | Conmed Andover Medical, Inc. | 1994-10-17 | Traditional | PDF ↗ |
| K941977 | TAYLOR LONG TERM MONITORING ELECTRODE | Taylor Industries, Inc. | 1994-09-21 | Traditional | PDF ↗ |
| K935281 | ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1994-09-06 | Traditional | PDF ↗ |
| K934000 | SENTRY AQUEOUS GEL ECG ELECTRODES | Sentry Medical Products, Inc. | 1994-08-30 | Traditional | PDF ↗ |
| K940801 | K-KLIP | Katecho, Inc. | 1994-08-03 | Traditional | PDF ↗ |
| K942925 | CONMED ANDOVER MED ECG ELECTRODES | Conmed Andover Medical, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K934333 | 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE | 3M Medical Products Group | 1994-07-07 | Traditional | PDF ↗ |
| K940802 | ZIPPREP ELECTRODE | Aspect Medical Systems, Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K940586 | K-SNAP | Katecho, Inc. | 1994-06-09 | Traditional | PDF ↗ |
| K931457 | NDM SILVON ECG ELECTRODES | Ndm Acquisition Corp. | 1993-11-23 | Traditional | PDF ↗ |
| K931903 | SURELOCK(TM) SNAPLESS MONITORING ELECTRODE | Ludlow Technical Products | 1993-10-07 | Traditional | PDF ↗ |
| K930312 | 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE | 3M Health Care, Ltd. | 1993-09-01 | Traditional | PDF ↗ |
| K932454 | 3M RED DOT 2330 RESTING EKG ELECTRODE | 3M Health Care, Ltd. | 1993-08-16 | Traditional | PDF ↗ |
| K930258 | TRACET T-6000 | Lectec Corp. | 1993-04-16 | Traditional | PDF ↗ |
| K921164 | MODEL 1300 SOFTRACE II ELECTRODE | Medtronic Vascular | 1993-03-18 | Traditional | PDF ↗ |
| K923558 | ECG ELECTRODE | Lectec Corp. | 1993-02-18 | Traditional | PDF ↗ |
| K911518 | BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM | Lead-Lok, Inc. | 1992-11-09 | Traditional | PDF ↗ |
| K911529 | BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG | Lead-Lok, Inc. | 1992-11-09 | Traditional | PDF ↗ |
| K924133 | ELECTROTRACE, MODIFICATION | Jason Marketing Co. | 1992-10-30 | Traditional | PDF ↗ |
| K921207 | DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION | Physiometrix, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K921579 | BR-50-J DISPOSABLE ECG ELECTRODE | Medicotest, Inc. | 1992-05-26 | Traditional | PDF ↗ |
| K920867 | EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG | Electro Medical Equipment Co., Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K914672 | QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE | Medicotest, Inc. | 1991-10-31 | Traditional | PDF ↗ |
| K911472 | BIO-SENSOR 01 EKG ELECTRODE | Bio-Sensor, Inc. | 1991-10-10 | Traditional | PDF ↗ |
| K911687 | VER-MED A10020 RESTING EKG ELECTRODE | Vermont Medical, Inc. | 1991-10-10 | Traditional | PDF ↗ |
| K913226 | MODEL #810 STEALTH-STIM ADULT STIMULATION PADS | Cardiotronics, Inc. | 1991-09-04 | Traditional | PDF ↗ |
| K912450 | TRACETS SME 5000 | Lectec Corp. | 1991-08-28 | Traditional | PDF ↗ |
| K910139 | VER-MED A10014 RESTING EKG ELECTRODE & A10021 | Vermont Medical, Inc. | 1991-08-15 | Traditional | PDF ↗ |
| K912714 | RT40 RADIO TRANSLUCENT | Bio-Detek, Inc. | 1991-07-25 | Traditional | PDF ↗ |
| K911990 | ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. | Somnitec, Inc. | 1991-06-21 | Traditional | PDF ↗ |
| K910494 | RESTING EKG ELECTRODE SERIES | Medtronic Andover Medical, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K905489 | VER-MED A10017 UNIVERSAL ELECTRODE | Vermont Medical, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K905729 | CANMED 451 | Andover Medical, Inc. | 1991-02-07 | Traditional | PDF ↗ |
| K905446 | MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE | Medtronic Andover Medical, Inc. | 1991-02-05 | Traditional | PDF ↗ |
| K904512 | TRACET AG 4000 | Lectec Corp. | 1991-01-31 | Traditional | PDF ↗ |
| K903491 | MONITRODE | Lleventon | 1990-12-17 | Traditional | PDF ↗ |
| K903555 | ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC. | Jason Marketing Co. | 1990-11-05 | Traditional | PDF ↗ |
| K903918 | MODEL 1850 ELECTRODE | Medtronic Vascular | 1990-10-31 | Traditional | PDF ↗ |
| K904185 | SENSATRACE | Ludlow Corp., Technical Papers Division | 1990-10-31 | Traditional | PDF ↗ |
| K902176 | SILVER MACTRODE | Marquette Electronics, Inc. | 1990-09-04 | Traditional | PDF ↗ |
| K902738 | ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH | Labeltape Meditect, Inc. | 1990-09-04 | Traditional | PDF ↗ |
| K902407 | NF-50-E DISPOSABLE ECG ELECTRODE | Medicotest, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K901555 | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE | Medtronic Vascular | 1990-07-18 | Traditional | PDF ↗ |
| K902080 | RED DOT 2269 INFANT MONITORING ELECTRODE | 3M Company | 1990-07-18 | Traditional | PDF ↗ |
| K900519 | CLASSIC ECG/STIMULATING NO. 1700 SERIES | Classic Medical Products, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K896569 | ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. | Jason Marketing Co. | 1990-01-18 | Traditional | PDF ↗ |
| K896155 | RED DOT CARDIAC SENSOR SYSTEM | 3M Company | 1989-12-13 | Traditional | PDF ↗ |
| K895834 | BABY MAC ELECTROCARDIOGRAPH ELECTRODE | Marquette Electronics, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K894991 | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. | Labeltape Meditect, Inc. | 1989-10-26 | Traditional | PDF ↗ |
| K894462 | CARE DISP. DIAG. ELECTRODES, SILVER/SILVER | Labeltape Meditect, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K894920 | SELECTRODE | S & W Medico Teknik | 1989-10-03 | Traditional | PDF ↗ |
| K894679 | ELECTROTRACE DISP. RESTING EKG ELECTRODES | Jason Marketing Co. | 1989-09-13 | Traditional | PDF ↗ |
| K894648 | ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO | Arbo Medical, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K894562 | ARBO H79P DISPOSABLE MONITORING ELECTRODES | Arbo Medical, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K893425 | VITATRACE | Lectec Corp. | 1989-07-14 | Traditional | PDF ↗ |
| K893245 | L30-LB- INFANT LIMB BAND | Contour Electrodes, Inc. | 1989-06-20 | Traditional | PDF ↗ |
| K884980 | F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM | S & W Medico Teknik | 1989-05-01 | Traditional | PDF ↗ |
| K891075 | BARD NEONATAL ECG MONITORING ELECTRODE | C.R. Bard, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K890201 | RADIOLUCENT ECG ELECTRODE MODEL NO: 1680 | Medtronic Vascular | 1989-03-15 | Traditional | PDF ↗ |
| K884981 | F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM | S & W Medico Teknik | 1989-03-10 | Traditional | PDF ↗ |
| K884982 | M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68 | S & W Medico Teknik | 1989-03-10 | Traditional | PDF ↗ |
| K884983 | M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 | S & W Medico Teknik | 1989-03-09 | Traditional | PDF ↗ |
| K884984 | M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 | S & W Medico Teknik | 1989-03-09 | Traditional | PDF ↗ |
| K885306 | NUPREP | Weaver & Co. | 1989-02-23 | Traditional | PDF ↗ |
| K884775 | ARBO PINK H82P | Arbo Medical, Inc. | 1989-02-06 | Traditional | PDF ↗ |
| K885262 | POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES | Valleylab, Inc. | 1989-01-25 | Traditional | PDF ↗ |
| K890103 | BARD TAB ECG MONITORING ELECTRODE | C.R. Bard, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K883643 | TDK ECG ELECTRODE, MEL-10L | Tdk Corp. | 1988-11-17 | Traditional | PDF ↗ |
| K884064 | BARD MULTI-TAC ECG MONITORING ELECTRODE | C.R. Bard, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K882904 | TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 | Tdk Corp. | 1988-10-05 | Traditional | PDF ↗ |
| K882216 | SYNCOR (R) MODEL S-801 ECG ELECTRODE | Lectec Corp. | 1988-07-20 | Traditional | PDF ↗ |
| K881085 | SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE | Contour Electrodes, Inc. | 1988-04-11 | Traditional | PDF ↗ |
| K875015 | TRACETS 3000 | Lectec Corp. | 1988-01-28 | Traditional | PDF ↗ |
| K874423 | PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E | Hewlett-Packard Co. | 1988-01-28 | Traditional | PDF ↗ |
| K874424 | PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E | Hewlett-Packard Co. | 1988-01-28 | Traditional | PDF ↗ |
| K872866 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE) | Labeltape Meditect, Inc. | 1988-01-28 | Traditional | PDF ↗ |
Product code DRX · Class II · Cardiovascular. Data: openFDA.