Cleared Traditional

RT40 RADIO TRANSLUCENT

K912714 · Bio-Detek, Inc. · Cardiovascular
Jul 1991
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K912714 is an FDA 510(k) clearance for the RT40 RADIO TRANSLUCENT, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bio-Detek, Inc. (Attleboro, US). The FDA issued a Cleared decision on July 25, 1991, 37 days after receiving the submission on June 18, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K912714 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1991
Decision Date July 25, 1991
Days to Decision 37 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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