510(k) K254183

MR Conditional Cup Electrodes by Technomed Europe — Product Code GXY

K254183 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "MR Conditional Cup Electrodes". The FDA issued a decision of Substantially Equivalent on May 7, 2026. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Technomed Europe has at least 10 other 510(k) clearances on record.