Cleared Traditional

SECURATRODE

K874562 · Meddev International Corp. · Cardiovascular
Jan 1988
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K874562 is an FDA 510(k) clearance for the SECURATRODE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Meddev International Corp. (Los Altos, US). The FDA issued a Cleared decision on January 28, 1988, 85 days after receiving the submission on November 4, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K874562 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1987
Decision Date January 28, 1988
Days to Decision 85 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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