510(k) K240668

Amydi-med Disposable Non-invasive EEG electrodes by Shenzhen Amydi-Med Electrics Tech Co., Ltd. — Product Code GXY

K240668 is an FDA 510(k) premarket notification submitted by Shenzhen Amydi-Med Electrics Tech Co., Ltd. for the device "Amydi-med Disposable Non-invasive EEG electrodes". The FDA issued a decision of Substantially Equivalent on Mar 19, 2024. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320.