SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM

SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM is an FDA 510(k)-cleared medical device (K050209) 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 November 22, 2005. Regulation: 8.