Cleared Traditional

BOWEN REUSEABLE/DISPOSABLE ELECTRODE

K871325 · Bowen & Company, Inc. · Cardiovascular
Jun 1987
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K871325 is an FDA 510(k) clearance for the BOWEN REUSEABLE/DISPOSABLE ELECTRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on June 8, 1987, 66 days after receiving the submission on April 3, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K871325 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1987
Decision Date June 08, 1987
Days to Decision 66 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

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