Clearance Summary
BIOFIND received FDA 510(k) clearance under submission number K003480, sponsored by Bio-Scan, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-05-11.
- Submission: K003480
- Applicant / Sponsor: Bio-Scan, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1540
- Decision date: 2001-05-11
Classification & Regulation
This clearance is catalogued under FDA product code GZO and 21 CFR 882.1540, within the Neurology review panel as a Class II device.