DRX · Class II · 21 CFR 870.2360

FDA Product Code DRX: Electrode, Electrocardiograph

Leading manufacturers include Graphic Controls Corp., Nikomed U.S.A., Inc. and Lectec Corp..

329
Total
329
Cleared
123d
Avg days
1976
Since

FDA 510(k) Cleared Electrode, Electrocardiograph Devices (Product Code DRX)

329 devices
1–24 of 329
Cleared Aug 23, 2017
Physiotrace
K171244
Nimbleheart, Inc.
Cardiovascular · 117d
Cleared Jul 24, 2014
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
K140096
Hmicro, Inc.
Cardiovascular · 191d
Cleared Apr 24, 2013
BIOMODULE 3-M1
K123658
Zephyr Technology Corporation
Cardiovascular · 147d
Cleared Jul 22, 2010
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
K101576
Team Innovations, Inc.
Cardiovascular · 45d
Cleared Jul 01, 2010
IP-SET
K101685
Integral Process Sas
Cardiovascular · 15d
Cleared Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129
Ambu A/S
Cardiovascular · 143d
Cleared May 10, 2010
INTCO TAB ELECTRODE
K093327
Shanghai Intco Electrode Manufacturing Co., Ltd.
Cardiovascular · 196d
Cleared Apr 23, 2010
12 LEAD GLOVE
K100315
I Needmd, Inc.
Cardiovascular · 78d
Cleared Dec 10, 2009
NEONATAL ECG ELECTRODE, M203KEN
K092744
R & D Medical Products, Inc.
Cardiovascular · 93d
Cleared Oct 13, 2009
DISPOSAL ECG ELECTRODES, MODEL EASYRODE
K092389
Suzuken Co., Ltd.
Cardiovascular · 69d
Cleared Sep 01, 2009
QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
K090496
Cardiac Lead Technologies, Inc.
Cardiovascular · 188d
Cleared Aug 21, 2009
SKINTACT AND VARIOUS OTHER TRADENAMES
K092291
Leonhard Lang GmbH
Cardiovascular · 23d
Cleared Aug 07, 2009
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
K091856
Conmed Corporation
Cardiovascular · 45d
Cleared Jun 17, 2009
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
K090180
Vermed, Inc.
Cardiovascular · 145d
Cleared Mar 10, 2009
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
K083677
Commwell , Ltd.
Cardiovascular · 89d
Cleared Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
K083148
Bio Protech, Inc.
Cardiovascular · 14d
Cleared Sep 25, 2008
AUDICOR SENSOR, MODELS: 2.0, 3.0
K080602
Inovise Medical, Inc.
Cardiovascular · 206d
Cleared Feb 01, 2008
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
K080106
Leonhard Lang GmbH
Cardiovascular · 17d
Cleared Nov 16, 2007
SKINTACT AND VARIOUS OTHER TRADENAMES
K073104
Leonhard Lang GmbH
Cardiovascular · 14d
Cleared Nov 02, 2007
TEXTRONICS ECG ELECTRODE
K071576
Textronics, Inc.
Cardiovascular · 147d
Cleared Mar 23, 2007
CARDIOBELT ELECTRODE BELT
K063044
Monebo Technologies, Inc.
Cardiovascular · 170d
Cleared Dec 11, 2006
ORI F6T DRY ECG MONITORING ELECTRODE
K062760
Orbital Research, Inc.
Cardiovascular · 87d
Cleared Oct 25, 2006
AMBU WHITE SENSOR CFM, CFL
K052944
Ambu A/S
Cardiovascular · 370d
Cleared Oct 25, 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550
Ambu A/S
Cardiovascular · 309d

About Product Code DRX - Regulatory Context