DYONICS VISION 111 MOBILE VIDEO UNIT

DYONICS VISION 111 MOBILE VIDEO UNIT is an FDA 510(k)-cleared medical device (K010489) manufactured by Smith & Nephew, Inc.. 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 April 9, 2001. Regulation: 8.