Clearance Summary
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT received FDA 510(k) clearance under submission number K964132, sponsored by Bio-Logic Systems Corp.. 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 1997-05-13.
- Submission: K964132
- Applicant / Sponsor: Bio-Logic Systems Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1997-05-13
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.