DRX · Class II · 21 CFR 870.2360

FDA Product Code DRX: Electrode, Electrocardiograph

Leading manufacturers include Medtronic Vascular, Hewlett-Packard Co. and C.R. Bard, Inc..

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

1 2 3 4

Cleared Mar 18, 1993

MODEL 1300 SOFTRACE II ELECTRODE

K921164

Medtronic Vascular

Cardiovascular · 372d

MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE

K901555

Medtronic Vascular

Cardiovascular · 106d

Cleared Jul 18, 1990

RED DOT 2269 INFANT MONITORING ELECTRODE

RED DOT CARDIAC SENSOR SYSTEM

BARD NEONATAL ECG MONITORING ELECTRODE

RADIOLUCENT ECG ELECTRODE MODEL NO: 1680

BARD TAB ECG MONITORING ELECTRODE

BARD MULTI-TAC ECG MONITORING ELECTRODE

PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A

PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D

PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E

PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E

MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK

RED DOT MONITORING ELECTRODES #2260/65

BARD BIOMEDICAL PRINTED SILVER ELECTRODE

ECG CLUSTER ELECTRODE

K771776

C.R. Bard, Inc.

Cardiovascular · 51d

1 2 3 4

About Product Code DRX - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Aug 23, 2017

Product Code Info

Code	DRX
Device class	Class II
CFR	21 CFR 870.2360
Panel	Cardiovascular

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View DRX classification on FDA.gov →