510(k) K180045

Omnipod DASH Insulin Management System by Insulet Corporation — Product Code LZG

K180045 is an FDA 510(k) premarket notification submitted by Insulet Corporation for the device "Omnipod DASH Insulin Management System". The FDA issued a decision of Substantially Equivalent on June 1, 2018. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Insulet Corporation has at least 10 other 510(k) clearances on record.