Clearance Summary
AUDIOMETER CALIBRATOR MODEL RA 310 received FDA 510(k) clearance under submission number K780474, sponsored by Tracor 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 1978-03-30.
- Submission: K780474
- Applicant / Sponsor: Tracor Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.1080
- Decision date: 1978-03-30
Classification & Regulation
This clearance is catalogued under FDA product code EWA and 21 CFR 874.1080, within the Ear, Nose, Throat review panel as a Class I device.