Cleared Traditional

SENTRY AQUEOUS GEL ECG ELECTRODES

K934000 · Sentry Medical Products, Inc. · Cardiovascular
Aug 1994
Decision
378d
Days
Class 2
Risk

About This 510(k) Submission

K934000 is an FDA 510(k) clearance for the SENTRY AQUEOUS GEL ECG ELECTRODES, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Sentry Medical Products, Inc. (Lombard, US). The FDA issued a Cleared decision on August 30, 1994, 378 days after receiving the submission on August 17, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K934000 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1993
Decision Date August 30, 1994
Days to Decision 378 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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