510(k) K203079

MR Conditional Sticky Pad Electrode by Rhythmlink International, LLC — Product Code GXY

K203079 is an FDA 510(k) premarket notification submitted by Rhythmlink International, LLC for the device "MR Conditional Sticky Pad Electrode". The FDA issued a decision of Substantially Equivalent on February 9, 2021. 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.