510(k) K992044

INFUSION DYNAMICS POWER INFUSER MODEL M100B by Infusion Dynamics, Inc. — Product Code FRN

K992044 is an FDA 510(k) premarket notification submitted by Infusion Dynamics, Inc. for the device "INFUSION DYNAMICS POWER INFUSER MODEL M100B". The FDA issued a decision of Substantially Equivalent on September 8, 1999. 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.