MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER is an FDA 510(k)-cleared medical device (K002409) manufactured by Automatic Medical Technologies, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2001. Regulation: 8.