Clearance Summary
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER received FDA 510(k) clearance under submission number K081841, sponsored by Amplivox, Ltd.. 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 2008-07-16.
- Submission: K081841
- Applicant / Sponsor: Amplivox, Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 2008-07-16
Classification & Regulation
This clearance is catalogued under FDA product code ETY and 21 CFR 874.1090, within the Ear, Nose, Throat review panel as a Class II device.