510(k) K172503

MR Conditional Cup Electrode, MR Conditional Webb Electrode by Rhythmlink International, LLC — Product Code GXY

K172503 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 December 1, 2017. 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.