MINIMED PARADIGM INSULIN PUMP, MODEL 511

MINIMED PARADIGM INSULIN PUMP, MODEL 511 is an FDA 510(k)-cleared medical device (K001829) manufactured by Minimed, 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 August 17, 2000. Regulation: 8.