Cleared Traditional

STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE

K964224 · Pmt Corp. · Neurology
Mar 1997
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K964224 is an FDA 510(k) clearance for the STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE, a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on March 19, 1997, 147 days after receiving the submission on October 23, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K964224 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1996
Decision Date March 19, 1997
Days to Decision 147 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYC — Electrode, Cortical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1310

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