Clearance Summary
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS received FDA 510(k) clearance under submission number K043219, sponsored by Interacoustics AS. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2005-02-04.
- Submission: K043219
- Applicant / Sponsor: Interacoustics AS
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 2005-02-04
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.