Clearance Summary
Aegis Transit System received FDA 510(k) clearance under submission number K170757, sponsored by Boston-Biomedical Associates. 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 2017-07-14.
- Submission: K170757
- Applicant / Sponsor: Boston-Biomedical Associates
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4720
- Decision date: 2017-07-14
Classification & Regulation
This clearance is catalogued under FDA product code EWY and 21 CFR 874.4720, within the Ear, Nose, Throat review panel as a Class II device.