Product code DRX
- Device name
- Electrode, Electrocardiograph
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2360
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171244 | Physiotrace | Nimbleheart, Inc. | 2017-08-23 |
| K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Hmicro, Inc. | 2014-07-24 |
| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | 2013-04-24 |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Team Innovations, Inc. | 2010-07-22 |
| K101685 | IP-SET | Integral Process Sas | 2010-07-01 |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | 2010-06-11 |
| K093327 | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 |
| K100315 | 12 LEAD GLOVE | I Needmd, Inc. | 2010-04-23 |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | 2009-12-10 |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | 2009-10-13 |
| K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Cardiac Lead Technologies, Inc. | 2009-09-01 |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2009-08-21 |
| K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | Conmed Corporation | 2009-08-07 |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | 2009-06-17 |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | 2009-03-10 |
| K083148 | TELECTRODE WET GEL ECG ELECTRODE | Bio Protech, Inc. | 2008-11-07 |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Inovise Medical, Inc. | 2008-09-25 |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Leonhard Lang GmbH | 2008-02-01 |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2007-11-16 |
| K071576 | TEXTRONICS ECG ELECTRODE | Textronics, Inc. | 2007-11-02 |
| K063044 | CARDIOBELT ELECTRODE BELT | Monebo Technologies, Inc. | 2007-03-23 |
| K062760 | ORI F6T DRY ECG MONITORING ELECTRODE | Orbital Research, Inc. | 2006-12-11 |
| K052944 | AMBU WHITE SENSOR CFM, CFL | Ambu A/S | 2006-10-25 |
| K053550 | AMBU BLUE SENSOR NEO AND NEO X | Ambu A/S | 2006-10-25 |
| K060661 | MACTRODE 3 | Ge Medical Systems Information Technologies | 2006-04-07 |
| K053011 | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 | Bio Protech, Inc. | 2005-12-14 |
| K050443 | ACCU-LEAD | Kentec Medical, Inc. | 2005-09-02 |
| K050248 | ELECTRODE | Electramold | 2005-05-25 |
| K043361 | ACCUHEART ELECTRODE BELT | Advanced Bioelectric Corporation | 2005-03-22 |
| K033559 | 12-LEAD GLOVE | Ineedmd | 2004-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033003267424 | NA | FIAB SPA | 2021-03-31 |
| 08033003260364 | NA | FIAB SPA | 2020-06-13 |
| 08033695726094 | NA | FIAB SPA | 2020-06-13 |
| 08033695726032 | NA | FIAB SPA | 2020-06-13 |
| 08033695725936 | NA | FIAB SPA | 2020-06-13 |
| 08033695725639 | NA | FIAB SPA | 2020-06-13 |
| 08033695725417 | NA | FIAB SPA | 2020-06-13 |
| 08033695725318 | NA | FIAB SPA | 2020-06-13 |
| 08033695723369 | NA | FIAB SPA | 2020-06-13 |
| 08033695722041 | NA | FIAB SPA | 2020-06-13 |
| 08033695722034 | NA | FIAB SPA | 2020-06-13 |
| 08033695722027 | NA | FIAB SPA | 2020-06-13 |
| 08033695721983 | NA | FIAB SPA | 2020-06-13 |
| 08033003264577 | NA | FIAB SPA | 2020-06-13 |
| 08033003262887 | NA | FIAB SPA | 2020-06-13 |
| 08033003262733 | NA | FIAB SPA | 2020-06-13 |
| 08033003262726 | NA | FIAB SPA | 2020-06-13 |
| 08033003262719 | NA | FIAB SPA | 2020-06-13 |
| 08033003262689 | NA | FIAB SPA | 2020-06-13 |
| 08033003261682 | NA | FIAB SPA | 2020-06-13 |
| 08033003261675 | NA | FIAB SPA | 2020-06-13 |
| 08033003261507 | NA | FIAB SPA | 2020-06-13 |
| 08033003260371 | NA | FIAB SPA | 2020-06-13 |
| 08033003260357 | NA | FIAB SPA | 2020-06-13 |
| 08033003263365 | NA | FIAB SPA | 2020-06-12 |
| 08033003263532 | NA | FIAB SPA | 2020-06-12 |
| 08033003263648 | NA | FIAB SPA | 2020-06-12 |
| 08033003263297 | NA | FIAB SPA | 2020-06-12 |
| 08033003263273 | NA | FIAB SPA | 2020-06-12 |
| 08033003261569 | NA | FIAB SPA | 2020-06-12 |