Clearance Summary
EB-1830T3, VIDEO BRONCHOSCOPE received FDA 510(k) clearance under submission number K023376, sponsored by Pentax Precision Instrument Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2002-10-16.
- Submission: K023376
- Applicant / Sponsor: Pentax Precision Instrument Corp.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2002-10-16
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.