Clearance Summary
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER received FDA 510(k) clearance under submission number K881099, sponsored by Phonic Ear, Inc.. 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 1988-06-07.
- Submission: K881099
- Applicant / Sponsor: Phonic Ear, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3320
- Decision date: 1988-06-07
Classification & Regulation
This clearance is catalogued under FDA product code EPF and 21 CFR 874.3320, within the Ear, Nose, Throat review panel as a Class II device.