510(k) K180761

SD LTM STIM Cortical Stimulator by Micromed S.P.A. — Product Code GYC

K180761 is an FDA 510(k) premarket notification submitted by Micromed S.P.A. for the device "SD LTM STIM Cortical Stimulator". The FDA issued a decision of Substantially Equivalent on June 18, 2018. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Micromed S.P.A. has at least 6 other 510(k) clearances on record.