Clearance Summary
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 received FDA 510(k) clearance under submission number K862086, sponsored by A/S Bruel & Kjaer. 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 1986-07-16.
- Submission: K862086
- Applicant / Sponsor: A/S Bruel & Kjaer
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 1986-07-16
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.