Clearance Summary
MINI-CEARS COMPUTER (MODEL 1) received FDA 510(k) clearance under submission number K800001, sponsored by Bik Foundation, 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 1980-01-31.
- Submission: K800001
- Applicant / Sponsor: Bik Foundation, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1420
- Decision date: 1980-01-31
Classification & Regulation
This clearance is catalogued under FDA product code GWS and 21 CFR 882.1420, within the Neurology review panel as a Class I device.