Clearance Summary
TITAN received FDA 510(k) clearance under submission number K103760, sponsored by Interacoustics 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 2011-05-05.
- Submission: K103760
- Applicant / Sponsor: Interacoustics A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 2011-05-05
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.