DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088

DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 is an FDA 510(k)-cleared medical device (K011944) 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 September 18, 2001. Regulation: 8.