510(k) K111669

FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS by Insulet Corporation — Product Code LZG

K111669 is an FDA 510(k) premarket notification submitted by Insulet Corporation for the device "FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS". The FDA issued a decision of Substantially Equivalent on Dec 15, 2011. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Insulet Corporation has 23 other 510(k) clearances on record.