Clearance Summary
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT received FDA 510(k) clearance under submission number K974658, 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 1998-02-25.
- Submission: K974658
- 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: 1998-02-25
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.