EVIS EXERA II 180 SYSTEM

EVIS EXERA II 180 SYSTEM is an FDA 510(k)-cleared medical device (K062049) 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 September 21, 2006. Regulation: 8.