510(k) K131154

ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; by Zevex, Inc. — Product Code LZH

K131154 is an FDA 510(k) premarket notification submitted by Zevex, Inc. for the device "ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;". The FDA issued a decision of Substantially Equivalent on February 12, 2014. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Zevex, Inc. has at least 4 other 510(k) clearances on record.