T:SLIM (TM) INSULIN DELIVERY SYSTEM

T:SLIM (TM) INSULIN DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K111210) manufactured by Tandem Diabetes Care, 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 8, 2011. Regulation: 8.