Clearance Summary
EVOKED POTENTIAL SYS received FDA 510(k) clearance under submission number K842543, 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 1984-11-29.
- Submission: K842543
- Applicant / Sponsor: Bio-Logic Systems Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 1984-11-29
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.