510(k) K133532

ALARIS SYSTEM WITH GUARDRAILS SUITE MX by Carefusion 303, Inc. — Product Code FRN

K133532 is an FDA 510(k) premarket notification submitted by Carefusion 303, Inc. for the device "ALARIS SYSTEM WITH GUARDRAILS SUITE MX". The FDA issued a decision of Substantially Equivalent on August 21, 2014. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Carefusion 303, Inc. has at least 6 other 510(k) clearances on record.