Clearance Summary
FOCUS VNG/ENG TYPE 1068 received FDA 510(k) clearance under submission number K061791, sponsored by Gn Otometrics A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-07-11.
- Submission: K061791
- Applicant / Sponsor: Gn Otometrics A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1460
- Decision date: 2006-07-11
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.