Cleared Traditional

DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES

K853038 · Bio-Detek, Inc. · Cardiovascular
Jan 1986
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K853038 is an FDA 510(k) clearance for the DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bio-Detek, Inc. (Mansfield, US). The FDA issued a Cleared decision on January 7, 1986, 172 days after receiving the submission on July 19, 1985. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K853038 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1985
Decision Date January 07, 1986
Days to Decision 172 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