Cleared Traditional

CUTANEOUS ELECTRODE

K933802 · Cadwell Laboratories, Inc. · Neurology
Sep 1994
Decision
399d
Days
Class 2
Risk

About This 510(k) Submission

K933802 is an FDA 510(k) clearance for the CUTANEOUS 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 September 7, 1994, 399 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 K933802 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date September 07, 1994
Days to Decision 399 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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