OKTAS STEREO VIEWING SYSTEM

OKTAS STEREO VIEWING SYSTEM is an FDA 510(k)-cleared medical device (K944254) manufactured by Oktas. 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 November 29, 1994. Regulation: 8.