510(k) K051641

ALARIS SYSTEM PC UNIT, MODEL 8001 by Cardinal Health, Alaris Products — Product Code FRN

K051641 is an FDA 510(k) premarket notification submitted by Cardinal Health, Alaris Products for the device "ALARIS SYSTEM PC UNIT, MODEL 8001". The FDA issued a decision of Substantially Equivalent on October 20, 2005. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Cardinal Health, Alaris Products has at least 8 other 510(k) clearances on record.