DRX · Electrode, Electrocardiograph
Cardiovascular · 21 CFR 870.2360 · Class 2
Overview
| Product Code | DRX |
|---|---|
| Device Name | Electrode, Electrocardiograph |
| Regulation | 21 CFR 870.2360 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
Recent Cleared Devices (20 of 329)
Showing 20 most recent of 329 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171244 | Physiotrace | Nimbleheart, Inc. | Aug 23, 2017 | SESE |
| K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Hmicro, Inc. | Jul 24, 2014 | SESE |
| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | Apr 24, 2013 | SESE |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Team Innovations, Inc. | Jul 22, 2010 | SESE |
| K101685 | IP-SET | Integral Process Sas | Jul 1, 2010 | SESE |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | Jun 11, 2010 | SESE |
| K093327 | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | May 10, 2010 | SESE |
| K100315 | 12 LEAD GLOVE | I Needmd, Inc. | Apr 23, 2010 | SESE |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | Dec 10, 2009 | SESE |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | Oct 13, 2009 | SESE |
| K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Cardiac Lead Technologies, Inc. | Sep 1, 2009 | SESE |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | Aug 21, 2009 | SESE |
| K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | Conmed Corporation | Aug 7, 2009 | SESE |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | Jun 17, 2009 | SESE |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | Mar 10, 2009 | SESE |
| K083148 | TELECTRODE WET GEL ECG ELECTRODE | Bio Protech, Inc. | Nov 7, 2008 | SESE |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Inovise Medical, Inc. | Sep 25, 2008 | SESE |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Leonhard Lang GmbH | Feb 1, 2008 | SESE |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | Nov 16, 2007 | SESE |
| K071576 | TEXTRONICS ECG ELECTRODE | Textronics, Inc. | Nov 2, 2007 | SESE |
Top Applicants
- Graphic Controls Corp. — 17 clearances
- Nikomed U.S.A., Inc. — 12 clearances
- Lectec Corp. — 11 clearances
- Labeltape Meditect, Inc. — 10 clearances
- Andover Medical, Inc. — 8 clearances
