Product Code: DRX
FDA class 2
21 CFR 870.2360
Electrode, Electrocardiograph
Cardiovascular
The Electrocardiograph Electrode is a cardiovascular sensor device placed on the body surface to detect electrical potentials generated by the heart, providing the signal input for electrocardiographic recording and analysis. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRX and it is regulated under 21 CFR 870.2360 within the Cardiovascular medical specialty.
510(k)s
329
FEI Numbers
191
Registration Numbers
191
Unique Applicants
146
Years Active
41
Basic Information
- Product Code
- DRX
- Device Class
- FDA class 2
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 329 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K171244 | Physiotrace | Aug 23, 2017 | Substantially Equivalent | NimbleHeart, Inc. |
| K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Jul 24, 2014 | Substantially Equivalent | HMICRO, INC. |
| K123658 | BIOMODULE 3-M1 | Apr 24, 2013 | Substantially Equivalent | ZEPHYR TECHNOLOGY CORPORATION |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Jul 22, 2010 | Substantially Equivalent | TEAM INNOVATIONS, INC |
| K101685 | IP-SET | Jul 01, 2010 | Substantially Equivalent | INTEGRAL PROCESS SAS |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Jun 11, 2010 | Substantially Equivalent | AMBU A/S |
| K093327 | INTCO TAB ELECTRODE | May 10, 2010 | Substantially Equivalent | SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. |
| K100315 | 12 LEAD GLOVE | Apr 23, 2010 | Substantially Equivalent | I NEEDMD, INC |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | Dec 10, 2009 | Substantially Equivalent | R & D MEDICAL PRODUCTS, INC. |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Oct 13, 2009 | Substantially Equivalent | SUZUKEN CO., LTD. |
| K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Sep 01, 2009 | Substantially Equivalent | CARDIAC LEAD TECHNOLOGIES, INC. |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Aug 21, 2009 | Substantially Equivalent | LEONHARD LANG GMBH |
| K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | Aug 07, 2009 | Substantially Equivalent | CONMED CORPORATION |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Jun 17, 2009 | Substantially Equivalent | VERMED, INC. |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Mar 10, 2009 | Substantially Equivalent | COMMWELL LTD. |
| K083148 | TELECTRODE WET GEL ECG ELECTRODE | Nov 07, 2008 | Substantially Equivalent | BIO PROTECH, INC. |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Sep 25, 2008 | Substantially Equivalent | INOVISE MEDICAL, INC. |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Feb 01, 2008 | Substantially Equivalent | LEONHARD LANG GMBH |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | Nov 16, 2007 | Substantially Equivalent | LEONHARD LANG GMBH |
| K071576 | TEXTRONICS ECG ELECTRODE | Nov 02, 2007 | Substantially Equivalent | TEXTRONICS, INC |
| K063044 | CARDIOBELT ELECTRODE BELT | Mar 23, 2007 | Substantially Equivalent | MONEBO TECHNOLOGIES, INC. |
| K062760 | ORI F6T DRY ECG MONITORING ELECTRODE | Dec 11, 2006 | Substantially Equivalent | ORBITAL RESEARCH INC. |
| K053550 | AMBU BLUE SENSOR NEO AND NEO X | Oct 25, 2006 | Substantially Equivalent | AMBU A/S |
| K052944 | AMBU WHITE SENSOR CFM, CFL | Oct 25, 2006 | Substantially Equivalent | AMBU A/S |
| K060661 | MACTRODE 3 | Apr 07, 2006 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K053011 | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 | Dec 14, 2005 | Substantially Equivalent | BIO PROTECH, INC. |
| K050443 | ACCU-LEAD | Sep 02, 2005 | Substantially Equivalent | KENTEC MEDICAL, INC. |
| K050248 | ELECTRODE | May 25, 2005 | Substantially Equivalent | ELECTRAMOLD |
| K043361 | ACCUHEART ELECTRODE BELT | Mar 22, 2005 | Substantially Equivalent | ADVANCED BIOELECTRIC CORPORATION |
| K033559 | 12-LEAD GLOVE | Dec 22, 2004 | Substantially Equivalent | INEEDMD |
| K041734 | AMBU DISPOSABLE ECG ELECTRODE | Sep 22, 2004 | Substantially Equivalent | AMBU, INC. |
| K041954 | DISPOSABLE MONITORING ELECTRODES | Sep 15, 2004 | Substantially Equivalent | SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. |
| K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S | Jun 28, 2004 | Substantially Equivalent | AMBU, INC. |
| K040784 | PROTAB ECG TABB ELECTRODE | Apr 07, 2004 | Substantially Equivalent | BIO PROTECH, INC. |
| K040249 | SKINTACT ECG ELECTRODE | Feb 24, 2004 | Substantially Equivalent | LEONHARD LANG GMBH |
| K030316 | AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) | Aug 07, 2003 | Substantially Equivalent | INOVISE MEDICAL, INC. |
| K031174 | BODY SIGNAL ECG ELECTRODE | Jul 10, 2003 | Substantially Equivalent | WANDY RUBBER INDUSTRIAL CO., LTD |
| K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | Mar 28, 2003 | Substantially Equivalent | VERMONT MEDICAL, INC. |
| K030509 | SKINTACT ECG TAB ELECTRODE | Mar 04, 2003 | Substantially Equivalent | LEONHARD LANG GMBH |
| K024264 | SKINTACT | Jan 16, 2003 | Substantially Equivalent | LEONHARD LANG CO. |
| K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL | Jan 16, 2003 | Substantially Equivalent | LEONHARD LANG GMBH |
| K023920 | SKINTACT | Jan 16, 2003 | Substantially Equivalent | LEONHARD LANG GMBH |
| K022909 | NIKOMED TRACE 1 ECG ELECTRODES | Jan 09, 2003 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K023503 | SKINTACT ECG ELECTRODE | Nov 14, 2002 | Substantially Equivalent | LEONHARD LANG GMBH |
| K020003 | ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE | Nov 07, 2002 | Substantially Equivalent | BIO PROTECH, INC. |
| K020382 | BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA | Jun 28, 2002 | Substantially Equivalent | MEDICOTEST A/S |
| K011564 | NEOLEAD | Jan 03, 2002 | Substantially Equivalent | NEOTECH PRODUCTS, INC. |
| K003804 | SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 | Aug 30, 2001 | Substantially Equivalent | NIKO MEDICAL PRODUCTS |
| K002230 | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 | Aug 18, 2000 | Substantially Equivalent | CAMBRIDGE HEART, INC. |
| K993934 | V QUICK PATCH | Aug 15, 2000 | Substantially Equivalent | VQ CORP. |
| K000690 | 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE | May 17, 2000 | Substantially Equivalent | MINNESOTA MINING AND MFG. CO. |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | Apr 13, 2000 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K990115 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 | Dec 06, 1999 | Substantially Equivalent | MAERSK MEDICAL A/S |
| K990113 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 | Dec 06, 1999 | Substantially Equivalent | MAERSK MEDICAL A/S |
| K990112 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 | Dec 06, 1999 | Substantially Equivalent | MAERSK MEDICAL A/S |
| K990111 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 | Dec 06, 1999 | Substantially Equivalent | MAERSK MEDICAL A/S |
| K990110 | DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 | Dec 06, 1999 | Substantially Equivalent | MAERSK MEDICAL A/S |
| K991105 | ECG ELECTRODE (VARIOUS) | Nov 26, 1999 | Substantially Equivalent | CONMED CORP. |
| K982521 | SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES | Oct 26, 1999 | Substantially Equivalent | LEONHARD LANG CO. |
| K983689 | BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES | Jan 15, 1999 | Substantially Equivalent | MEDICOTEST A/S |
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | Nov 13, 1998 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K982470 | ECG ELECTRODES APRON | Oct 14, 1998 | Substantially Equivalent | TAPUZ MEDICAL TECHNOLOGY LTD. |
| K974445 | 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 | Jul 26, 1998 | Substantially Equivalent | 3M HEALTH CARE |
| K973663 | PALJET-B | Feb 10, 1998 | Substantially Equivalent | GOLDEN GATE BIO-DEVICE |
| K973727 | ELECTRODE, ELECTROCARDIOGRAPH | Dec 19, 1997 | Substantially Equivalent | DON TAY INDUSTRIES |
| K972001 | NICAS(TM) ELECTRODE | Jul 08, 1997 | Substantially Equivalent | NI MEDICAL |
| K971444 | 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES | Jun 11, 1997 | Substantially Equivalent | 3M MEDICAL PRODUCTS GROUP |
| K970755 | STEALTHSHIELD | Apr 15, 1997 | Substantially Equivalent | VITAL CONNECTIONS, INC. |
| K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES | Apr 09, 1997 | Substantially Equivalent | 3M HEALTH CARE |
| K963787 | EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM | Mar 11, 1997 | Substantially Equivalent | CONMED CORP. |
| K970125 | NOAH MONITORING ELECTRODE SYSTEM | Mar 04, 1997 | Substantially Equivalent | CONTOUR MEDICAL TECHNOLOGY, INC. |
| K963975 | VERSATEC 310 ELECTRODE | Jan 07, 1997 | Substantially Equivalent | VERSATEC, INC. |
| K963159 | CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES | Dec 11, 1996 | Substantially Equivalent | CMC SENSE-IT, INC. |
| K961643 | MEDICOTEST ECG ELECTRODES | Dec 09, 1996 | Substantially Equivalent | MEDICOTEST, INC. |
| K964213 | TRACE RITE SOLID GEL ECG ELECTRODES | Nov 25, 1996 | Substantially Equivalent | BIO-DETEK, INC. |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | Nov 19, 1996 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | Nov 15, 1996 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | Oct 28, 1996 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K962115 | CAMBRIDGE HEART HI-RES ECG ELECTRODE | Aug 29, 1996 | Substantially Equivalent | CAMBRIDGE HEART, INC. |
| K961288 | BODYTRODE | Aug 08, 1996 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K962122 | SENTRY RADIOTRANSLUCENT ECG ELECTRODES | Jul 24, 1996 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K955815 | G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE | Jul 23, 1996 | Substantially Equivalent | CMC SENSE-IT, INC. |
| K960721 | PACEART WRIST ELECTRODES | Jul 18, 1996 | Substantially Equivalent | PACEART, INC. |
| K954773 | QUICKELS QS 100 SYSTEM | Jul 11, 1996 | Substantially Equivalent | FERGUSON MEDICAL |
| K954772 | QUICKELS QS 200 SYSTEM | Jul 11, 1996 | Substantially Equivalent | FERGUSON MEDICAL |
| K953649 | DISPOSABLE ECG ELECTRODE | Jun 21, 1996 | Substantially Equivalent | KENDALL-LTP |
| K961395 | MEDI-TRACE RADIOLUCENT | Jun 07, 1996 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K955800 | SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE | May 17, 1996 | Substantially Equivalent | CMC SENSE-IT, INC. |
| K944497 | UNILECT, MONITAB AND BIOTRACE-HR | May 17, 1996 | Substantially Equivalent | MSB LTD. |
| K954389 | CONMED ECG/EKG ELECTRODES | May 16, 1996 | Substantially Equivalent | CONMED CORP. |
| K944496 | BIOTRACE-N, NS, 410 AND RT | May 16, 1996 | Substantially Equivalent | MSB LTD. |
| K960264 | CONMED EKG STRIPPER | Apr 09, 1996 | Substantially Equivalent | CONMED CORP. |
| K954388 | CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE | Feb 06, 1996 | Substantially Equivalent | CONMED CORP. |
| K950473 | DISPOSABLE ECG MONITORING ELECTRODE | Dec 12, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950475 | DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 | Nov 14, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950472 | DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM | Nov 14, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950480 | DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM | Nov 06, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950478 | DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM | Nov 06, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950477 | DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM | Nov 06, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950474 | DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM | Nov 06, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950471 | DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM | Nov 06, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950470 | DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM | Nov 06, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950587 | ECOTABS | Oct 16, 1995 | Substantially Equivalent | MSB LTD. |
| K950479 | DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM | Sep 13, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950476 | DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM | Sep 06, 1995 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K950485 | GRAPHIC CONTROLS PROTRACE ECG ELECTRODE | Jul 07, 1995 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K945479 | MEDI-TRACE(R) 500 ECG ELECTRODE | Jul 07, 1995 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K944260 | ECG ELECTRODE | Jul 07, 1995 | Substantially Equivalent | MSB LTD. |
| K950489 | GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE | Jul 03, 1995 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K950488 | GRAPHIC CONTROLS BIOTAC ECO ELECTRODE | Jul 03, 1995 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K945836 | 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES | Jun 20, 1995 | Substantially Equivalent | CONMED ANDOVER MEDICAL, INC. |
| K950487 | GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE | May 17, 1995 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K950486 | GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE | May 17, 1995 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K946273 | 1700 MONITORING ECG ELECTRODE | May 17, 1995 | Substantially Equivalent | CONMED ANDOVER MEDICAL, INC. |
| K935437 | ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES | Apr 06, 1995 | Substantially Equivalent | ARBO MEDICAL, INC. |
| K932903 | EKG VEST | Feb 24, 1995 | Substantially Equivalent | CARDIOTRONICS, INC. |
| K943301 | QUIK COMBO | Feb 03, 1995 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K935371 | R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD | Dec 02, 1994 | Substantially Equivalent | R2 MEDICAL SYSTEMS |
| K944726 | 1710 MONITORING ECG ELECTRODE | Nov 22, 1994 | Substantially Equivalent | CONMED ANDOVER MEDICAL, INC. |
| K944655 | ECG ELECTRODE | Nov 22, 1994 | Substantially Equivalent | CONMED ANDOVER MEDICAL, INC. |
| K934505 | TRIGEL MULTIFUNCTION ELECTRODE | Nov 22, 1994 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K935246 | ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES | Nov 16, 1994 | Substantially Equivalent | ARBO MEDICAL, INC. |
| K945214 | MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE | Nov 10, 1994 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K935429 | ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES | Nov 01, 1994 | Substantially Equivalent | ARBO MEDICAL, INC. |
| K944849 | 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE | Oct 17, 1994 | Substantially Equivalent | CONMED ANDOVER MEDICAL, INC. |
| K941977 | TAYLOR LONG TERM MONITORING ELECTRODE | Sep 21, 1994 | Substantially Equivalent | TAYLOR INDUSTRIES, INC. |
| K935281 | ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES | Sep 06, 1994 | Substantially Equivalent | ARBO MEDICAL, INC. |
| K934000 | SENTRY AQUEOUS GEL ECG ELECTRODES | Aug 30, 1994 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K940801 | K-KLIP | Aug 03, 1994 | Substantially Equivalent | KATECHO, INC. |
| K942925 | CONMED ANDOVER MED ECG ELECTRODES | Jul 20, 1994 | Substantially Equivalent | CONMED ANDOVER MEDICAL, INC. |
| K934333 | 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE | Jul 07, 1994 | Substantially Equivalent | 3M MEDICAL PRODUCTS GROUP |
| K940802 | ZIPPREP ELECTRODE | Jun 22, 1994 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K940586 | K-SNAP | Jun 09, 1994 | Substantially Equivalent | KATECHO, INC. |
| K931457 | NDM SILVON ECG ELECTRODES | Nov 23, 1993 | Substantially Equivalent | NDM ACQUISITION CORP. |
| K931903 | SURELOCK(TM) SNAPLESS MONITORING ELECTRODE | Oct 07, 1993 | Substantially Equivalent | LUDLOW TECHNICAL PRODUCTS |
| K930312 | 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE | Sep 01, 1993 | Substantially Equivalent | 3M HEALTH CARE, LTD. |
| K932454 | 3M RED DOT 2330 RESTING EKG ELECTRODE | Aug 16, 1993 | Substantially Equivalent | 3M HEALTH CARE, LTD. |
| K930258 | TRACET T-6000 | Apr 16, 1993 | Substantially Equivalent | LECTEC CORP. |
| K921164 | MODEL 1300 SOFTRACE II ELECTRODE | Mar 18, 1993 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K923558 | ECG ELECTRODE | Feb 18, 1993 | Substantially Equivalent | LECTEC CORP. |
| K911529 | BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG | Nov 09, 1992 | Substantially Equivalent | LEAD-LOK, INC. |
| K911518 | BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM | Nov 09, 1992 | Substantially Equivalent | LEAD-LOK, INC. |
| K924133 | ELECTROTRACE, MODIFICATION | Oct 30, 1992 | Substantially Equivalent | JASON MARKETING CO. |
| K921207 | DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION | Oct 13, 1992 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K921579 | BR-50-J DISPOSABLE ECG ELECTRODE | May 26, 1992 | Substantially Equivalent | MEDICOTEST, INC. |
| K920867 | EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG | Apr 10, 1992 | Substantially Equivalent | ELECTRO MEDICAL EQUIPMENT CO., INC. |
| K914672 | QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE | Oct 31, 1991 | Substantially Equivalent | MEDICOTEST, INC. |
| K911687 | VER-MED A10020 RESTING EKG ELECTRODE | Oct 10, 1991 | Substantially Equivalent | VERMONT MEDICAL, INC. |
| K911472 | BIO-SENSOR 01 EKG ELECTRODE | Oct 10, 1991 | Substantially Equivalent | BIO-SENSOR, INC. |
| K913226 | MODEL #810 STEALTH-STIM ADULT STIMULATION PADS | Sep 04, 1991 | Substantially Equivalent | CARDIOTRONICS, INC. |
| K912450 | TRACETS SME 5000 | Aug 28, 1991 | Substantially Equivalent | LECTEC CORP. |
| K910139 | VER-MED A10014 RESTING EKG ELECTRODE & A10021 | Aug 15, 1991 | Substantially Equivalent | VERMONT MEDICAL, INC. |
| K912714 | RT40 RADIO TRANSLUCENT | Jul 25, 1991 | Substantially Equivalent | BIO-DETEK, INC. |
| K911990 | ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. | Jun 21, 1991 | Substantially Equivalent | SOMNITEC, INC. |
| K910494 | RESTING EKG ELECTRODE SERIES | Apr 22, 1991 | Substantially Equivalent | MEDTRONIC ANDOVER MEDICAL, INC. |
| K905489 | VER-MED A10017 UNIVERSAL ELECTRODE | Mar 21, 1991 | Substantially Equivalent | VERMONT MEDICAL, INC. |
| K905729 | CANMED 451 | Feb 07, 1991 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K905446 | MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE | Feb 05, 1991 | Substantially Equivalent | MEDTRONIC ANDOVER MEDICAL, INC. |
| K904512 | TRACET AG 4000 | Jan 31, 1991 | Substantially Equivalent | LECTEC CORP. |
| K903491 | MONITRODE | Dec 17, 1990 | Substantially Equivalent | LLEVENTON |
| K903555 | ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC. | Nov 05, 1990 | Substantially Equivalent | JASON MARKETING CO. |
| K904185 | SENSATRACE | Oct 31, 1990 | Substantially Equivalent | LUDLOW CORP., TECHNICAL PAPERS DIVISION |
| K903918 | MODEL 1850 ELECTRODE | Oct 31, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K902738 | ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH | Sep 04, 1990 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K902176 | SILVER MACTRODE | Sep 04, 1990 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K902407 | NF-50-E DISPOSABLE ECG ELECTRODE | Jul 31, 1990 | Substantially Equivalent | MEDICOTEST, INC. |
| K902080 | RED DOT 2269 INFANT MONITORING ELECTRODE | Jul 18, 1990 | Substantially Equivalent | 3M COMPANY |
| K901555 | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE | Jul 18, 1990 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K900519 | CLASSIC ECG/STIMULATING NO. 1700 SERIES | Mar 19, 1990 | Substantially Equivalent | CLASSIC MEDICAL PRODUCTS, INC. |
| K896569 | ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. | Jan 18, 1990 | Substantially Equivalent | JASON MARKETING CO. |
| K896155 | RED DOT CARDIAC SENSOR SYSTEM | Dec 13, 1989 | Substantially Equivalent | 3M COMPANY |
| K895834 | BABY MAC ELECTROCARDIOGRAPH ELECTRODE | Nov 03, 1989 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K894991 | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. | Oct 26, 1989 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K894462 | CARE DISP. DIAG. ELECTRODES, SILVER/SILVER | Oct 12, 1989 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K894920 | SELECTRODE | Oct 03, 1989 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K894679 | ELECTROTRACE DISP. RESTING EKG ELECTRODES | Sep 13, 1989 | Substantially Equivalent | JASON MARKETING CO. |
| K894648 | ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO | Sep 05, 1989 | Substantially Equivalent | ARBO MEDICAL, INC. |
| K894562 | ARBO H79P DISPOSABLE MONITORING ELECTRODES | Sep 05, 1989 | Substantially Equivalent | ARBO MEDICAL, INC. |
| K893425 | VITATRACE | Jul 14, 1989 | Substantially Equivalent | LECTEC CORP. |
| K893245 | L30-LB- INFANT LIMB BAND | Jun 20, 1989 | Substantially Equivalent | CONTOUR ELECTRODES, INC. |
| K884980 | F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM | May 01, 1989 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K891075 | BARD NEONATAL ECG MONITORING ELECTRODE | Mar 22, 1989 | Substantially Equivalent | C.R. BARD, INC. |
| K890201 | RADIOLUCENT ECG ELECTRODE MODEL NO: 1680 | Mar 15, 1989 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K884982 | M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68 | Mar 10, 1989 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K884981 | F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM | Mar 10, 1989 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K884984 | M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 | Mar 09, 1989 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K884983 | M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 | Mar 09, 1989 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K885306 | NUPREP | Feb 23, 1989 | Substantially Equivalent | WEAVER & CO. |
| K884775 | ARBO PINK H82P | Feb 06, 1989 | Substantially Equivalent | ARBO MEDICAL, INC. |
| K885262 | POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES | Jan 25, 1989 | Substantially Equivalent | VALLEYLAB, INC. |
| K890103 | BARD TAB ECG MONITORING ELECTRODE | Jan 24, 1989 | Substantially Equivalent | C.R. BARD, INC. |
| K883643 | TDK ECG ELECTRODE, MEL-10L | Nov 17, 1988 | Substantially Equivalent | TDK CORP. |
| K884064 | BARD MULTI-TAC ECG MONITORING ELECTRODE | Oct 06, 1988 | Substantially Equivalent | C.R. BARD, INC. |
| K882904 | TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 | Oct 05, 1988 | Substantially Equivalent | TDK CORP. |
| K882216 | SYNCOR (R) MODEL S-801 ECG ELECTRODE | Jul 20, 1988 | Substantially Equivalent | LECTEC CORP. |
| K881085 | SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE | Apr 11, 1988 | Substantially Equivalent | CONTOUR ELECTRODES, INC. |
| K875041 | FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE | Jan 28, 1988 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K875015 | TRACETS 3000 | Jan 28, 1988 | Substantially Equivalent | LECTEC CORP. |
| K874562 | SECURATRODE | Jan 28, 1988 | Substantially Equivalent | MEDDEV INTERNATIONAL CORP. |
| K874424 | PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E | Jan 28, 1988 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K874423 | PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E | Jan 28, 1988 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K874422 | PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D | Jan 28, 1988 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K874421 | PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A | Jan 28, 1988 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K872866 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE) | Jan 28, 1988 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K874437 | TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE) | Dec 30, 1987 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K873682 | FERRIS ECG ELECTRODE W/HYDROGEL | Dec 29, 1987 | Substantially Equivalent | FERRIS MFG. CORP. |
| K874628 | RESUBMITTED STANDARD MICROPORE ECG ELECTRODE | Dec 07, 1987 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K873442 | ECG ELECTRODE SYSTEM | Nov 23, 1987 | Substantially Equivalent | HILTRODE, INC.(A/S) SUBSIDIARY MUNKENES A/S |
| K872871 | NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) | Oct 16, 1987 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K872784 | MACTRODE-II | Oct 09, 1987 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K871441 | ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE | Aug 03, 1987 | Substantially Equivalent | NITTO DENKO AMERICA, INC. |
| K871748 | THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE | Jun 10, 1987 | Substantially Equivalent | THE BUDDY SYSTEMS, INC. |
| K871668 | BIODAN TYPE COMET ELECTRODE | Jun 10, 1987 | Substantially Equivalent | NATIONAL MEDICAL TECHNOLOGY |
| K871325 | BOWEN REUSEABLE/DISPOSABLE ELECTRODE | Jun 08, 1987 | Substantially Equivalent | BOWEN & COMPANY, INC. |
| K871626 | ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200 | Jun 05, 1987 | Substantially Equivalent | JASON MARKETING CO. |
| K871412 | CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO | May 12, 1987 | Substantially Equivalent | CONTOUR ELECTRODES, INC. |
| K864260 | APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) | May 11, 1987 | Substantially Equivalent | GRANDCOR MEDICAL SYSTEMS |
| K864690 | ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD | May 06, 1987 | Substantially Equivalent | MULTI BIOSENSORS, INC. |
| K870873 | MD MONITORING/DIAGNOSTIC ELECTRODE | Apr 10, 1987 | Substantially Equivalent | LECTEC CORP. |
| K870834 | TDK ECG ELECTRODE MEL-10 | Mar 23, 1987 | Substantially Equivalent | TDK CORP. |
| K865011 | PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER | Mar 13, 1987 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K864586 | S&W ELECTRODE TYPES 888, 844, 988 AND 944 | Mar 13, 1987 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K863674 | TRACETS 2000/ELECTRODES | Mar 11, 1987 | Substantially Equivalent | LECTEC CORP. |
| K864722 | MEDI-TRACE INFANT ELECTRODE | Feb 10, 1987 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K864868 | MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK | Jan 14, 1987 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K863904 | DISPOSABLE ECG MONITORING ELECTRODE | Jan 06, 1987 | Substantially Equivalent | CLINICAL DATA, INC. |
| K863369 | MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES | Jan 06, 1987 | Substantially Equivalent | TDK CORP. |
| K863584 | EM II STRESS TEST ELECTRODE | Dec 08, 1986 | Substantially Equivalent | ELECTROMED INTL., LTD. |
| K863540 | EM II DISPOSABLE ELECTRODE | Dec 08, 1986 | Substantially Equivalent | ELECTROMED INTL., LTD. |
| K863366 | PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE | Nov 21, 1986 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K863845 | EM III DISPOSABLE ELECTRODE | Nov 20, 1986 | Substantially Equivalent | ELECTROMED INTL., LTD. |
| K862618 | SKINTACT AG ELECTRODES | Sep 15, 1986 | Substantially Equivalent | LEON H. LANG CO. |
| K862765 | EUROMED S-601 | Aug 06, 1986 | Substantially Equivalent | LECTEC CORP. |
| K862746 | EM DIAGNOSTIC ECG ELECTRODE | Aug 06, 1986 | Substantially Equivalent | ELECTROMED INTL., LTD. |
| K862655 | SIGNA II RESTING ECG ELECTRODE | Aug 06, 1986 | Substantially Equivalent | KONE INSTRUMENTS, INC. |
| K861246 | PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD | Aug 06, 1986 | Substantially Equivalent | CONMED CORP. |
| K861099 | GEREONICS BIOPOTENTIAL SKIN ELECTRODES | Aug 06, 1986 | Substantially Equivalent | GEREONICS, INC. |
| K861158 | S&W TYPE 888 ELECTRODE | Jul 01, 1986 | Substantially Equivalent | NATIONAL MEDICAL TECHNOLOGY |
| K860827 | EM STRESS ELECTRODE | May 08, 1986 | Substantially Equivalent | ELECTROMED INTL., LTD. |
| K854433 | ECG MONITORING/DEFIBRILLATION ELECTRODE | May 08, 1986 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K854757 | 5000 SERIES ECG ELECTRODES | Apr 23, 1986 | Substantially Equivalent | ALTERNATIVE DESIGN SYSTEMS, INC. |
| K853774 | EM ELECTRODE | Apr 17, 1986 | Substantially Equivalent | ELECTROMED INTL., LTD. |
| K853939 | ECG-ELECTRODE(SWAROMED) | Apr 11, 1986 | Substantially Equivalent | D. SWAROVSKI & CO. |
| K853993 | DOBE (MODIFIED) | Feb 28, 1986 | Substantially Equivalent | PHOENIX MEDICAL TECHNOLOGY, INC. |
| K853705 | BOMED-EEA | Jan 13, 1986 | Substantially Equivalent | BOMED MEDICAL MFR., LTD. |
| K853038 | DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES | Jan 07, 1986 | Substantially Equivalent | BIO-DETEK, INC. |
| K851522 | DIAGNOSTIC ECG DISPOSABLE ELECTRODE | Oct 24, 1985 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K852469 | SAF-D-FIB | Sep 16, 1985 | Substantially Equivalent | MEDTRONIC ANDOVER MEDICAL, INC. |
| K851732 | CARBOCONE | Sep 16, 1985 | Substantially Equivalent | IMTECH CORP. |
| K852177 | FOAM ECG ELECTRODES | Aug 09, 1985 | Substantially Equivalent | CLINICAL DATA, INC. |
| K840445 | SYNKARA | May 16, 1985 | Substantially Equivalent | LECTEC CORP. |
| K850132 | DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC | Apr 09, 1985 | Substantially Equivalent | CONSOLIDATED MEDICAL EQUIPMENT, INC. |
| K850130 | PRN ECG ELECTRODE | Apr 09, 1985 | Substantially Equivalent | CONSOLIDATED MEDICAL EQUIPMENT, INC. |
| K842514 | ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD | Mar 01, 1985 | Substantially Equivalent | MULTI BIOSENSORS, INC. |
| K841944 | DISPOSABLE ECG ELECTRODE | Mar 01, 1985 | Substantially Equivalent | BRISTOL MEDICAL ELECTRONICS CORP. |
| K850085 | DISPOSABLE ECG ELECTRODES EASATRACE | Feb 27, 1985 | Substantially Equivalent | MEDICAL DEVICE MARKETING |
| K844856 | ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON | Feb 20, 1985 | Substantially Equivalent | BRISTOL MEDICAL ELECTRONICS CORP. |
| K844632 | INFANT LIMB ELECTRODE | Jan 14, 1985 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K844345 | CONTOUR ELECTRODE | Jan 02, 1985 | Substantially Equivalent | HEURISTIC MEDICAL SYSTEMS, INC. |
| K844335 | ELECTROCARDIOGRAPH ELECTRODE | Jan 02, 1985 | Substantially Equivalent | MEDITECT |
| K844100 | CANMED 101 | Dec 27, 1984 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K844099 | CANMED 102 | Dec 27, 1984 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K840646 | CARDIOTRODE | Oct 26, 1984 | Substantially Equivalent | KHOLBER CORP. |
| K840465 | Q-MED ELECTRODE | Jun 19, 1984 | Substantially Equivalent | QMED, INC. |
| K832903 | ESOPHOGRAL MULTIPROBE | May 23, 1984 | Substantially Equivalent | VITAL SIGNS, INC. |
| K832429 | CARDIO TRACE ELECTRODE | May 09, 1984 | Substantially Equivalent | POLY-MED SPLINT CO. |
| K834445 | MEDI-TRACE QUIKSET DX DIAG. ELECT- | Apr 01, 1984 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K833899 | TDK ECG ELECTRODE MEL-08 | Feb 10, 1984 | Substantially Equivalent | TDK CORP. |
| K833695 | ADULT MONITORING ELECTOR@@RODE 9431-300 | Jan 27, 1984 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K832877 | PRE-GELLED DISPOS ELECTRODE | Dec 22, 1983 | Substantially Equivalent | ADVANCE TECH INTL. |
| K832516 | MAGNATRODE CARDIAC MONITORING ELECTRODE | Dec 16, 1983 | Substantially Equivalent | R2 CORP. |
| K831977 | C TEC SERIES 9000 E.C.G. ELECTRODE | Sep 09, 1983 | Substantially Equivalent | SPEYWOOD MEDICAL, LTD. |
| K830655 | QUIK-SILVER RESTING ECG ELECTRODE | Jun 15, 1983 | Substantially Equivalent | QUINTON, INC. |
| K830362 | INFANT ELECTRODE BELT | Jun 03, 1983 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K830663 | PENCIL SKIN ABRADER | Apr 28, 1983 | Substantially Equivalent | NDM CORP. |
| K822750 | MEDI-TRACE 5' OFFSET ELECTRODE | Nov 01, 1982 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K822798 | DISPOSABLE ELECTRODE #1900 | Oct 15, 1982 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K821846 | LDS MONITORING ELECTRODE | Jul 30, 1982 | Substantially Equivalent | LIFE DESIGN SYSTEMS, INC. |
| K821802 | CENTURION ELECTRODE BELT | Jul 30, 1982 | Substantially Equivalent | CLINICAL DATA, INC. |
| K821434 | EKG (ECG) ELECTRODES | Jul 30, 1982 | Substantially Equivalent | DUPACO, INC. |
| K821535 | VITALINE DISPOSABLE EKG ELECTRODE-LEAD | Jul 08, 1982 | Substantially Equivalent | THE HALVERSTADT CO. |
| K821757 | QUIK - PREP2 ELECTRODE | Jul 02, 1982 | Substantially Equivalent | QUINTON, INC. |
| K821506 | MEDICOTEST ECG ELECTRODES | Jun 17, 1982 | Substantially Equivalent | MEDICOTEST, INC. |
| K821438 | RED DOT MONITORING ELECTRODES #2260/65 | May 25, 1982 | Substantially Equivalent | 3M COMPANY |
| K821137 | MEDITRACE PELLET ELECTRODE | May 18, 1982 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K820122 | PIONEER II BACK PLATE ELECTRODE | Mar 01, 1982 | Substantially Equivalent | LIFE SCIENCE INSTRUMENTATION, INC. |
| K813176 | GEL ELECTRODE | Dec 29, 1981 | Substantially Equivalent | DYN-A-MED PRODUCTS |
| K813013 | GEL ELECTRODE | Nov 27, 1981 | Substantially Equivalent | ARNDT AUTOMATION & ASSOC. |
| K812878 | THE NEW 1600 ELECTRODE | Nov 02, 1981 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K812276 | DISPOSABLE ELECTRODE, #1610 | Sep 25, 1981 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K810895 | ESOPHAGEAL PILL ELECTRODE | May 13, 1981 | Substantially Equivalent | CON MED EQUIPMENT, INC. |
| K810563 | QUINTON LTE ELECTRODE | Mar 17, 1981 | Substantially Equivalent | QUINTON, INC. |
| K803179 | DISPOSABLE ELECTRODE FOR EKG | Mar 11, 1981 | Substantially Equivalent | MIDWEST MONITORING |
| K810103 | ADULT ECG ELECTRODE #60-0724 | Jan 29, 1981 | Substantially Equivalent | ASPEN LABORATORIES, INC. |
| K810102 | INFANT ECG ELECTRODE #60-1029 | Jan 29, 1981 | Substantially Equivalent | ASPEN LABORATORIES, INC. |
| K802576 | EXTERNAL JUGULAR CVP CATHERIZATION KIT | Nov 12, 1980 | Substantially Equivalent | WILLSON |
| K801846 | ELECTROCARDIOGRAPH ELECTRODE | Sep 09, 1980 | Substantially Equivalent | PHOENIX GLOVE CO. |
| K800935 | R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) | May 23, 1980 | Substantially Equivalent | R2 CORP. |
| K800930 | R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. | May 23, 1980 | Substantially Equivalent | R2 CORP. |
| K800201 | ESOPHAGEAL PILL-ELECTRODE | Feb 26, 1980 | Substantially Equivalent | ARZBAECHER & CO. |
| K792436 | VXTRA BACK PACK EKG ELECTRODE CAT. NO. | Feb 22, 1980 | Substantially Equivalent | VXTRA CORP. |
| K792040 | BARD BIOMEDICAL PRINTED SILVER ELECTRODE | Nov 13, 1979 | Substantially Equivalent | C.R. BARD, INC. |
| K791140 | PREGELLED DISPOSABLE EELCTRO. SERIES 600 | Jul 10, 1979 | Substantially Equivalent | HAYES PRODUCTS, INC. |
| K791139 | PREGELLED DISPOSABLE ECG ELECTRODES | Jul 10, 1979 | Substantially Equivalent | HAYES PRODUCTS, INC. |
| K791006 | SMART BILECTRODES | Jun 11, 1979 | Substantially Equivalent | ELECTRONICS FOR MEDICINE, INC. |
| K791003 | ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA | Jun 01, 1979 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K791002 | ECG ELECTRODES, PEDIATRIC-FOAM TAPE | Jun 01, 1979 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K790959 | LIFEPATCH ECG ELECTRODES | May 31, 1979 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K790507 | 800 ECG ELECTRODE | May 18, 1979 | Substantially Equivalent | SIMONSEN & WEELS EFTF. |
| K790730 | NDM PAPER TAPE ECG ELECTRODE | Apr 26, 1979 | Substantially Equivalent | NDM CORP. |
| K790305 | ELECTRODES, FERRIS ECG, TYPES 905,906 | Apr 03, 1979 | Substantially Equivalent | FERRIS MFG. CORP. |
| K782079 | ELECTRODE SYSTEM, QUIK-PREP | Feb 01, 1979 | Substantially Equivalent | QUINTON, INC. |
| K781963 | ELECTRODES, OFFSET AND DX | Dec 19, 1978 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K781940 | EKG ELECTRODES, DISPOSABLE | Nov 29, 1978 | Substantially Equivalent | HAYES PRODUCTS, INC. |
| K781430 | PREGELLED DISPOSABLE E.K.G. ELECTRODE | Oct 31, 1978 | Substantially Equivalent | VERMONT MEDICAL, INC. |
| K781514 | ECG ELECTRODE, 2021, 2022, 2032, 2033 | Oct 17, 1978 | Substantially Equivalent | CARDIO-DYNAMICS LABORATORIES, INC. |
| K781518 | PREGELLED DISPOSABLE ELECTRODE | Oct 06, 1978 | Substantially Equivalent | VENTE MEDICAL PRODUCTS, INC. |
| K781163 | ELECTRODE, DEIP. | Sep 26, 1978 | Substantially Equivalent | DATASCOPE CORP. |
| K780908 | SELF-RETAINING ELECTRODE SER. #4000-100 | Jun 19, 1978 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K771776 | ECG CLUSTER ELECTRODE | Nov 09, 1977 | Substantially Equivalent | C.R. BARD, INC. |
| K771392 | ACCU-TRODE (DISP. ECG ELECTRODE) | Aug 16, 1977 | Substantially Equivalent | WARNER/CHILCOTT |
| K771447 | PREGELLED DISP. EKG MONITORING ELECT- | Aug 04, 1977 | Substantially Equivalent | HAYES PRODUCTS, INC. |
| K770988 | FOAM ECG ELECTRODE, 2060 AND 2061 | Jun 14, 1977 | Substantially Equivalent | CARDIO-DYNAMICS LABORATORIES, INC. |
| K770521 | ELECTROCARDIOGRAPHIC ELECTRODES, DISP. | Mar 29, 1977 | Substantially Equivalent | DOBRE, INC. |
| K770083 | LIFEPATCH TM ECG ELECTRODE | Feb 01, 1977 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K761301 | V-TRACE ECG BACKPAD | Jan 05, 1977 | Substantially Equivalent | NDM CORP. |
| K761249 | RADIO TRANSPARENT ECG ELECTRODE | Dec 21, 1976 | Substantially Equivalent | CONCEPT, INC. |
| K760358 | ELECTRODE SERIES 1600 | Aug 23, 1976 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K760280 | ELECTRODE SERIES 1401 | Aug 23, 1976 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
FEI Numbers
This FDA classification entry is associated with 191 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 191 registration numbers. Click on an entry to view related FDA registrations.