MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE

About This 510(k) Submission

K130287 is an FDA 510(k) clearance for the MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on May 30, 2013, 114 days after receiving the submission on February 5, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.