Cleared Traditional

CONCENTRIC EMG NEEDLE ELECTRODE

K933795 · Cadwell Laboratories, Inc. · Neurology
Apr 1994
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K933795 is an FDA 510(k) clearance for the CONCENTRIC EMG 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 22, 1994, 261 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 K933795 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date April 22, 1994
Days to Decision 261 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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