510(k) K163547

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 by Neurovirtual USA, Inc. — Product Code GXY

K163547 is an FDA 510(k) premarket notification submitted by Neurovirtual USA, Inc. for the device "MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96". The FDA issued a decision of Substantially Equivalent on April 11, 2017. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Neurovirtual USA, Inc. has at least 7 other 510(k) clearances on record.