510(k) K192603

Spes Medica Subdermal Needle Electrodes by Spes Medica Srl — Product Code GXZ

K192603 is an FDA 510(k) premarket notification submitted by Spes Medica Srl for the device "Spes Medica Subdermal Needle Electrodes". The FDA issued a decision of Substantially Equivalent on November 22, 2019. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Spes Medica Srl has at least 8 other 510(k) clearances on record.