510(k) K190050

Tech Dots - Adhesive and conductive gel by Spes Medica Srl — Product Code GYB

K190050 is an FDA 510(k) premarket notification submitted by Spes Medica Srl for the device "Tech Dots - Adhesive and conductive gel". The FDA issued a decision of Substantially Equivalent on July 19, 2019. 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.