CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400

CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 is an FDA 510(k)-cleared medical device (K982838) manufactured by Sims Deltec, 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 November 3, 1998. Regulation: 8.