510(k) K030739

INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE by Infusion Dynamics, Inc. — Product Code FRN

K030739 is an FDA 510(k) premarket notification submitted by Infusion Dynamics, Inc. for the device "INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE". The FDA issued a decision of Substantially Equivalent on January 14, 2004. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Infusion Dynamics, Inc. has at least 2 other 510(k) clearances on record.