Cleared Traditional

GROUND PLATE ELECTRODE

K933807 · Cadwell Laboratories, Inc. · Neurology
Jul 1994
Decision
356d
Days
Class 2
Risk

About This 510(k) Submission

K933807 is an FDA 510(k) clearance for the GROUND PLATE ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on July 26, 1994, 356 days after receiving the submission on August 4, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K933807 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date July 26, 1994
Days to Decision 356 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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

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