Clearance Summary
THE WESTERN CORTICAL ELECTRODE ARRAY received FDA 510(k) clearance under submission number K923330, sponsored by University Hospital (London) Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1993-11-09.
- Submission: K923330
- Applicant / Sponsor: University Hospital (London) Development Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1310
- Decision date: 1993-11-09
Classification & Regulation
This clearance is catalogued under FDA product code GYC and 21 CFR 882.1310, within the Neurology review panel as a Class II device.