Cleared Traditional

BIO-DETEK TRACERITE EEG ELECTRODE

K920264 · Bio-Detek, Inc. · Neurology
Jun 1992
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K920264 is an FDA 510(k) clearance for the BIO-DETEK TRACERITE EEG ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bio-Detek, Inc. (Attleboro, US). The FDA issued a Cleared decision on June 2, 1992, 133 days after receiving the submission on January 21, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K920264 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1992
Decision Date June 02, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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