Clearance Summary
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS received FDA 510(k) clearance under submission number K043090, 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 2004-12-23.
- Submission: K043090
- 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: 2004-12-23
Classification & Regulation
This clearance is catalogued under FDA product code LZI and 21 CFR 874.3320, within the Ear, Nose, Throat review panel as a Class II device.