PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318

PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 is an FDA 510(k)-cleared medical device (K001832) 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.