Clearance Summary
ASRA, SCREENING AUDIOMETER received FDA 510(k) clearance under submission number K914232, sponsored by Mercury Electronics (Scot) , Ltd.. 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 1992-01-31.
- Submission: K914232
- Applicant / Sponsor: Mercury Electronics (Scot) , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1992-01-31
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.