Clearance Summary
HEARING AID(ALL IN THE EAR(ALL IN THE CANAL received FDA 510(k) clearance under submission number K852052, sponsored by Penn-Tech Laboratories. 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 1985-08-16.
- Submission: K852052
- Applicant / Sponsor: Penn-Tech Laboratories
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1985-08-16
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.