510(k) K032147

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES by Alaris Medical Systems, Inc. — Product Code FRN

K032147 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES". The FDA issued a decision of Substantially Equivalent on July 25, 2003. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.