510(k) K203128

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS by Olympus Medical Systems Corp. — Product Code IYN

K203128 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS". The FDA issued a decision of Substantially Equivalent on Nov 9, 2020. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.