Cleared Traditional

BIO-DETEK EEG ELECTRODE

K920352 · Bio-Detek, Inc. · Neurology
Aug 1992
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K920352 is an FDA 510(k) clearance for the BIO-DETEK EEG ELECTRODE, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Bio-Detek, Inc. (Attleboro, US). The FDA issued a Cleared decision on August 14, 1992, 200 days after receiving the submission on January 27, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K920352 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1992
Decision Date August 14, 1992
Days to Decision 200 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXZ — Electrode, Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1350

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