HEATER COOLER UNIT, MODEL HCU 30

HEATER COOLER UNIT, MODEL HCU 30 is an FDA 510(k)-cleared medical device (K031544) manufactured by Jostra AB. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2003. Regulation: 8.