TRUEHD (1080P) DIGITAL CAMERA SYSTEM

TRUEHD (1080P) DIGITAL CAMERA SYSTEM is an FDA 510(k)-cleared medical device (K063457) manufactured by Conmed Linvatec. 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 December 4, 2006. Regulation: 8.