Clearance Summary
AUDIOMETER, RECORDING, AUTOMATIC received FDA 510(k) clearance under submission number K772169, sponsored by B&K Instruments, Inc.. 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 1977-12-02.
- Submission: K772169
- Applicant / Sponsor: B&K Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1977-12-02
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.