Cleared Traditional

TRACE RITE SOLID GEL ECG ELECTRODES

K964213 · Bio-Detek, Inc. · Cardiovascular
Nov 1996
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K964213 is an FDA 510(k) clearance for the TRACE RITE SOLID GEL ECG ELECTRODES, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bio-Detek, Inc. (Pawtucket, US). The FDA issued a Cleared decision on November 25, 1996, 34 days after receiving the submission on October 22, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K964213 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1996
Decision Date November 25, 1996
Days to Decision 34 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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