Cleared Traditional

DISPOSABLE ECG MONITORING ELECTRODE

K863904 · Clinical Data, Inc. · Cardiovascular
Jan 1987
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K863904 is an FDA 510(k) clearance for the DISPOSABLE ECG MONITORING ELECTRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Clinical Data, Inc. (Brookline, US). The FDA issued a Cleared decision on January 6, 1987, 91 days after receiving the submission on October 7, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K863904 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1986
Decision Date January 06, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRX — Electrode, Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2360

Similar Devices — DRX Electrode, Electrocardiograph

All 328
Physiotrace
K171244 · Nimbleheart, Inc. · Aug 2017
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
K140096 · Hmicro, Inc. · Jul 2014
BIOMODULE 3-M1
K123658 · Zephyr Technology Corporation · Apr 2013
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
K101576 · Team Innovations, Inc. · Jul 2010
IP-SET
K101685 · Integral Process Sas · Jul 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129 · Ambu A/S · Jun 2010