DRX — Electrode, Electrocardiograph Class II
FDA Device Classification
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 |