Clearance Summary
OLYMPUS BF TYPE UM40 received FDA 510(k) clearance under submission number K021204, sponsored by Olympus Optical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-05-01.
- Submission: K021204
- Applicant / Sponsor: Olympus Optical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2002-05-01
Classification & Regulation
This clearance is catalogued under FDA product code PSV and 21 CFR 892.1550, within the Radiology review panel as a Class II device.