Clearance Summary
CONDUCTIVE EEG ELECTROLYTE received FDA 510(k) clearance under submission number K033052, sponsored by Compumedics USA, 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 2003-12-17.
- Submission: K033052
- Applicant / Sponsor: Compumedics USA, Ltd.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 2003-12-17
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.