Clearance Summary
MODEL ST HEARING AID received FDA 510(k) clearance under submission number K861254, sponsored by Fine-Tune. 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 1986-04-23.
- Submission: K861254
- Applicant / Sponsor: Fine-Tune
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1986-04-23
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.