Cleared Traditional

WICK ELECTRODE, MODEL M019260

K063402 · Intelligent Hearing Systems · Neurology
Dec 2006
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K063402 is an FDA 510(k) clearance for the WICK ELECTRODE, MODEL M019260, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on December 11, 2006, 32 days after receiving the submission on November 9, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K063402 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2006
Decision Date December 11, 2006
Days to Decision 32 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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