Clearance Summary
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER received FDA 510(k) clearance under submission number K890497, sponsored by Monitor/Demlar. 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 1989-06-06.
- Submission: K890497
- Applicant / Sponsor: Monitor/Demlar
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1989-06-06
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.