510(k) K130287

MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE by Rhythmlink International, LLC — Product Code GXY

K130287 is an FDA 510(k) premarket notification submitted by Rhythmlink International, LLC for the device "MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 30, 2013. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Rhythmlink International, LLC has at least 10 other 510(k) clearances on record.