
Olympus Medical Systems Corporation
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OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER is an FDA 510(k)-cleared medical device (K043275) manufactured by Olympus Medical Systems Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2004. Regulation: 8.