STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM

STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K121893) manufactured by Stryker Endoscopy. 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 4, 2012. Regulation: 8.