Cleared Traditional

GROUND/REFERENCE NEEDLE ELECTRODE

K933793 · Cadwell Laboratories, Inc. · Neurology
Apr 1994
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K933793 is an FDA 510(k) clearance for the GROUND/REFERENCE NEEDLE ELECTRODE, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on April 19, 1994, 258 days after receiving the submission on August 4, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K933793 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date April 19, 1994
Days to Decision 258 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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

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