Cleared Traditional

EEG CUP ELECTRODE

K933808 · Cadwell Laboratories, Inc. · Neurology
Dec 1994
Decision
512d
Days
Class 2
Risk

About This 510(k) Submission

K933808 is an FDA 510(k) clearance for the EEG CUP 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 December 29, 1994, 512 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 K933808 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date December 29, 1994
Days to Decision 512 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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