Clearance Summary
Amydi-med Disposable Non-invasive EEG electrodes received FDA 510(k) clearance under submission number K240668, sponsored by Shenzhen Amydi-Med Electrics Tech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-03-19.
- Submission: K240668
- Applicant / Sponsor: Shenzhen Amydi-Med Electrics Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2024-03-19
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.