510(k) K031738

SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER by Smiths Medical MD, Inc. — Product Code LZG

K031738 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER". The FDA issued a decision of Substantially Equivalent on May 27, 2004. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.