Cleared Traditional

DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,

K091410 · Spes Medica Srl · Neurology
Aug 2009
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K091410 is an FDA 510(k) clearance for the DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on August 11, 2009, 90 days after receiving the submission on May 13, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K091410 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2009
Decision Date August 11, 2009
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IKT — Electrode, Needle, Diagnostic Electromyograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1385

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