Clearance Summary
REFUGE SOUND GENERATOR received FDA 510(k) clearance under submission number K041302, sponsored by Micro-Ear Technology, 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 2004-07-01.
- Submission: K041302
- Applicant / Sponsor: Micro-Ear Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2004-07-01
Classification & Regulation
This clearance is catalogued under FDA product code KLW and 21 CFR 874.3400, within the Ear, Nose, Throat review panel as a Class II device.