VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)

VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) is an FDA 510(k)-cleared medical device (K871418) manufactured by Critikon Company, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 1987. Regulation: 8.