Clearance Summary
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER received FDA 510(k) clearance under submission number K043275, sponsored by Olympus Medical Systems Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-12-09.
- Submission: K043275
- Applicant / Sponsor: Olympus Medical Systems Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2004-12-09
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.