Clearance Summary
VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV received FDA 510(k) clearance under submission number K880259, sponsored by Colorado Hearing Systems, Inc.. 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 1989-04-03.
- Submission: K880259
- Applicant / Sponsor: Colorado Hearing Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1989-04-03
Classification & Regulation
This clearance is catalogued under FDA product code LYN and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.