Clearance Summary
MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM received FDA 510(k) clearance under submission number K872633, sponsored by Hearing Health Care Program. 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 1987-09-16.
- Submission: K872633
- Applicant / Sponsor: Hearing Health Care Program
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 1987-09-16
Classification & Regulation
This clearance is catalogued under FDA product code ETW and 21 CFR 874.3310, within the Ear, Nose, Throat review panel as a Class II device.