560 HIGH DEFINITION CAMERA SYSTEM

560 HIGH DEFINITION CAMERA SYSTEM is an FDA 510(k)-cleared medical device (K070266) 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 February 21, 2007. Regulation: 8.