510(k) K200162

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) by Wuhan Greentek Pty , Ltd. — Product Code GXY

K200162 is an FDA 510(k) premarket notification submitted by Wuhan Greentek Pty , Ltd. for the device "Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)". The FDA issued a decision of Substantially Equivalent on April 21, 2020. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Wuhan Greentek Pty , Ltd. has at least 1 other 510(k) clearance on record.