Clearance Summary
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER received FDA 510(k) clearance under submission number K033108, sponsored by Vivosonic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2003-10-27.
- Submission: K033108
- Applicant / Sponsor: Vivosonic, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 2003-10-27
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.