510(k) K141492

ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) by Eurosets S.R.L — Product Code DTZ

K141492 is an FDA 510(k) premarket notification submitted by Eurosets S.R.L for the device "ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)". The FDA issued a decision of Substantially Equivalent on February 6, 2015. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Eurosets S.R.L has at least 5 other 510(k) clearances on record.