SYSTEMS INTEGRATION MODEL: ENDOALPHA

SYSTEMS INTEGRATION MODEL: ENDOALPHA is an FDA 510(k)-cleared medical device (K100345) manufactured by Olympus Medical Systems Corporation. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2010. Regulation: 8.