EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N is an FDA 510(k)-cleared medical device (K123317) 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 December 10, 2012. Regulation: 8.