Clearance Summary
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS received FDA 510(k) clearance under submission number K881011, sponsored by Bivona Medical Technologies. 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 1988-05-13.
- Submission: K881011
- Applicant / Sponsor: Bivona Medical Technologies
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3730
- Decision date: 1988-05-13
Classification & Regulation
This clearance is catalogued under FDA product code EWL and 21 CFR 874.3730, within the Ear, Nose, Throat review panel as a Class II device.