3S INJECTOR-CT CONTRAST DELIVERY SYSTEM

3S INJECTOR-CT CONTRAST DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K983826) manufactured by Unimachs Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 2000. Regulation: 8.