510(k) K041241

MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 by Alaris Medical Systems, Inc. — Product Code FRN

K041241 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600". The FDA issued a decision of Substantially Equivalent on July 6, 2004. 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.