Clearance Summary
PRIMUS HEARING INSTRUMENT TEST UNIT received FDA 510(k) clearance under submission number K113831, sponsored by Auditdata A/S. 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 2012-04-19.
- Submission: K113831
- Applicant / Sponsor: Auditdata A/S
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 2012-04-19
Classification & Regulation
This clearance is catalogued under FDA product code ETW and 21 CFR 874.3310, within the Ear, Nose, Throat review panel as a Class II device.