510(k) K023264

MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 by Alaris Medical Systems, Inc. — Product Code FRN

K023264 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110". The FDA issued a decision of Substantially Equivalent on December 19, 2002. 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.