ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS is an FDA 510(k)-cleared medical device (K011868) manufactured by Debio Tech SA. 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 September 3, 2001. Regulation: 8.