Clearance Summary
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR received FDA 510(k) clearance under submission number K882721, sponsored by Hear-O Inc. C/O L.P. Leale & Assoc.. 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 1988-09-15.
- Submission: K882721
- Applicant / Sponsor: Hear-O Inc. C/O L.P. Leale & Assoc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1988-09-15
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.