DUALTHERM(R) CARDIAC OUTPUT COMPUTER

DUALTHERM(R) CARDIAC OUTPUT COMPUTER is an FDA 510(k)-cleared medical device (K925285) manufactured by B. Braun of America, Inc.. 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 20, 1993. Regulation: 8.