Clearance Summary
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS received FDA 510(k) clearance under submission number K203128, sponsored by Olympus Medical Systems Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-11-09.
- Submission: K203128
- Applicant / Sponsor: Olympus Medical Systems Corp.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2020-11-09
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.