Clearance Summary
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) received FDA 510(k) clearance under submission number K200162, sponsored by Wuhan Greentek Pty , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-04-21.
- Submission: K200162
- Applicant / Sponsor: Wuhan Greentek Pty , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2020-04-21
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.