Cleared Traditional

PROTAB ECG TABB ELECTRODE

K040784 · Bio Protech, Inc. · Cardiovascular
Apr 2004
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K040784 is an FDA 510(k) clearance for the PROTAB ECG TABB ELECTRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on April 7, 2004, 9 days after receiving the submission on March 29, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K040784 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2004
Decision Date April 07, 2004
Days to Decision 9 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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