Cleared Traditional

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

K020003 · Bio Protech, Inc. · Cardiovascular
Nov 2002
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K020003 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bio Protech, Inc. (Sparks, US). The FDA issued a Cleared decision on November 7, 2002, 309 days after receiving the submission on January 2, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K020003 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2002
Decision Date November 07, 2002
Days to Decision 309 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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