Clearance Summary
FONIX TYPE 5100 HEARING AID ANALYZER received FDA 510(k) clearance under submission number K801905, sponsored by Frye Electronics, 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 1980-08-27.
- Submission: K801905
- Applicant / Sponsor: Frye Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 1980-08-27
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.