Clearance Summary
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 received FDA 510(k) clearance under submission number K043138, sponsored by Atos Medical AB. 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 2004-11-22.
- Submission: K043138
- Applicant / Sponsor: Atos Medical AB
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3730
- Decision date: 2004-11-22
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.