510(k) K132011

APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET by Aea Srl — Product Code FMF

K132011 is an FDA 510(k) premarket notification submitted by Aea Srl for the device "APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET". The FDA issued a decision of Substantially Equivalent on Mar 21, 2014. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Aea Srl has 2 other 510(k) clearances on record.