510(k) K212326

AC Cream - Conductive paste by Spes Medica Srl — Product Code GYB

K212326 is an FDA 510(k) premarket notification submitted by Spes Medica Srl for the device "AC Cream - Conductive paste". The FDA issued a decision of Substantially Equivalent on December 1, 2021. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Spes Medica Srl has at least 8 other 510(k) clearances on record.