Clearance Summary
ITE TYPE HEARING AID H.A.F. MODEL ELITE received FDA 510(k) clearance under submission number K881754, sponsored by Brown Hearing Aid Centers. 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 1988-07-25.
- Submission: K881754
- Applicant / Sponsor: Brown Hearing Aid Centers
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1988-07-25
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.