510(k) K162165

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump by Summit Medical Products, Inc. — Product Code MEA

K162165 is an FDA 510(k) premarket notification submitted by Summit Medical Products, Inc. for the device "ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump". The FDA issued a decision of Substantially Equivalent on August 29, 2017. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Summit Medical Products, Inc. has at least 3 other 510(k) clearances on record.