Cleared Traditional

EMG RECORDING ELECTRODE ASSEMBLY

K120342 · Rhythmlink International, LLC · Neurology
Jun 2012
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K120342 is an FDA 510(k) clearance for the EMG RECORDING ELECTRODE ASSEMBLY, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on June 22, 2012, 140 days after receiving the submission on February 3, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number K120342 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2012
Decision Date June 22, 2012
Days to Decision 140 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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