Cleared Traditional

MR CONDITIONAL PRESSON ELECTRODE

K130220 · Rhythmlink International, LLC · Neurology
Jul 2013
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K130220 is an FDA 510(k) clearance for the MR CONDITIONAL PRESSON ELECTRODE, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on July 22, 2013, 174 days after receiving the submission on January 29, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K130220 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2013
Decision Date July 22, 2013
Days to Decision 174 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXZ — Electrode, Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1350

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