Cleared Traditional

PMT TRUSCAN SURFACE ELECTRODE

K122376 · Pmt Corp. · Neurology
Dec 2012
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K122376 is an FDA 510(k) clearance for the PMT TRUSCAN SURFACE ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on December 19, 2012, 135 days after receiving the submission on August 6, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K122376 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2012
Decision Date December 19, 2012
Days to Decision 135 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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