Clearance Summary
INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) received FDA 510(k) clearance under submission number K900096, sponsored by Artifical Hearing Systems Corp.. 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 1990-05-31.
- Submission: K900096
- Applicant / Sponsor: Artifical Hearing Systems Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1990-05-31
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.