510(k) K231164

Conductive carbon film electrode by Guangzhou Xinbo Electronic Co., Ltd. — Product Code GXY

K231164 is an FDA 510(k) premarket notification submitted by Guangzhou Xinbo Electronic Co., Ltd. for the device "Conductive carbon film electrode". The FDA issued a decision of Substantially Equivalent on August 9, 2023. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Guangzhou Xinbo Electronic Co., Ltd. has at least 10 other 510(k) clearances on record.