DRX — Electrode, Electrocardiograph Class II
FDA product code DRX covers "Electrode, Electrocardiograph", a Class II medical device regulated under 21 CFR 870.2360. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRX
- Device Class
- Class II
- Regulation Number
- 870.2360
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171244 | nimbleheart | Physiotrace | August 23, 2017 |
| K140096 | hmicro | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | July 24, 2014 |
| K123658 | zephyr technology corporation | BIOMODULE 3-M1 | April 24, 2013 |
| K101576 | team innovations | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | July 22, 2010 |
| K101685 | integral process | IP-SET | July 1, 2010 |
| K100129 | ambu | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | June 11, 2010 |
| K093327 | shanghai intco electrode manufacturing co | INTCO TAB ELECTRODE | May 10, 2010 |
| K100315 | i needmd | 12 LEAD GLOVE | April 23, 2010 |
| K092744 | r and d medical products | NEONATAL ECG ELECTRODE, M203KEN | December 10, 2009 |
| K092389 | suzuken co | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | October 13, 2009 |
| K090496 | cardiac lead technologies | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | September 1, 2009 |
| K092291 | leonhard lang | SKINTACT AND VARIOUS OTHER TRADENAMES | August 21, 2009 |
| K091856 | conmed corporation | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 271 | August 7, 2009 |
| K090180 | vermed | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | June 17, 2009 |
| K083677 | commwell | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | March 10, 2009 |
| K083148 | bio protech | TELECTRODE WET GEL ECG ELECTRODE | November 7, 2008 |
| K080602 | inovise medical | AUDICOR SENSOR, MODELS: 2.0, 3.0 | September 25, 2008 |
| K080106 | leonhard lang | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | February 1, 2008 |
| K073104 | leonhard lang | SKINTACT AND VARIOUS OTHER TRADENAMES | November 16, 2007 |
| K071576 | textronics | TEXTRONICS ECG ELECTRODE | November 2, 2007 |