Cleared Traditional

TELECTRODE WET GEL ECG ELECTRODE

K083148 · Bio Protech, Inc. · Cardiovascular
Nov 2008
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K083148 is an FDA 510(k) clearance for the TELECTRODE WET GEL ECG ELECTRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bio Protech, Inc. (Woonju-Si, Gangwon-Do, KR). The FDA issued a Cleared decision on November 7, 2008, 14 days after receiving the submission on October 24, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K083148 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2008
Decision Date November 07, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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