510(k) K062323

DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 by Smiths Medical MD, Inc. — Product Code LZG

K062323 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817". The FDA issued a decision of Substantially Equivalent on November 1, 2006. 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.