Cleared Traditional

DISPOSABLE ADHESIVE SURFACE ELECTRODE

K120494 · Spes Medica Srl · Neurology
Jun 2012
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K120494 is an FDA 510(k) clearance for the DISPOSABLE ADHESIVE SURFACE ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on June 11, 2012, 115 days after receiving the submission on February 17, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K120494 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2012
Decision Date June 11, 2012
Days to Decision 115 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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