Clearance Summary
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK received FDA 510(k) clearance under submission number K081518, sponsored by Pentax Medical Company. 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 2008-09-05.
- Submission: K081518
- Applicant / Sponsor: Pentax Medical Company
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2008-09-05
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.