Clearance Summary
PE 400IR, PE 400T, PE 400E received FDA 510(k) clearance under submission number K923234, 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 1992-09-29.
- Submission: K923234
- 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: 1992-09-29
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.