Clearance Summary
EEG ANALYZER received FDA 510(k) clearance under submission number K925735, 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 1993-12-03.
- Submission: K925735
- Applicant / Sponsor: Bio-Scan, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1420
- Decision date: 1993-12-03
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.