510(k) K133593

T:SLIM INSULIN DELIVERY SYSTEM by Tandem Diabetes Care, Inc. — Product Code LZG

K133593 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care, Inc. for the device "T:SLIM INSULIN DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 2014. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Tandem Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.