Clearance Summary
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX received FDA 510(k) clearance under submission number K991642, sponsored by Bertec Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-08-03.
- Submission: K991642
- Applicant / Sponsor: Bertec Corp.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1460
- Decision date: 1999-08-03
Classification & Regulation
This clearance is catalogued under FDA product code GWN and 21 CFR 882.1460, within the Neurology review panel as a Class II device.