Clearance Summary
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. received FDA 510(k) clearance under submission number K994149, sponsored by Bio-Logic Systems Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-12-27.
- Submission: K994149
- Applicant / Sponsor: Bio-Logic Systems Corp.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 1999-12-27
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.