Clearance Summary
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX received FDA 510(k) clearance under submission number K934483, sponsored by Mountain Precision Mfg. Ltd. Co.. 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 1994-03-16.
- Submission: K934483
- Applicant / Sponsor: Mountain Precision Mfg. Ltd. Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3375
- Decision date: 1994-03-16
Classification & Regulation
This clearance is catalogued under FDA product code ESE and 21 CFR 874.3375, within the Ear, Nose, Throat review panel as a Class I device.