DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000

DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 is an FDA 510(k)-cleared medical device (K022834) manufactured by Ge Medical Systems Information Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2003. Regulation: 8.