Clearance Summary
CEEGRAPH received FDA 510(k) clearance under submission number K895125, sponsored by Bio-Logic Systems 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 1989-12-22.
- Submission: K895125
- Applicant / Sponsor: Bio-Logic Systems Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1989-12-22
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.