Clearance Summary
HEARING AID (ALL-IN-THE-EAR) received FDA 510(k) clearance under submission number K873189, sponsored by Sight-N-Sound & Co.. 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: K873189
- Applicant / Sponsor: Sight-N-Sound & Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1987-09-16
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.