510(k) K133958

FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 by Maquet Critical Care AB — Product Code BSZ

K133958 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "FLOW-I ANESTHESIA SYSTEM C20, C30 & C40". The FDA issued a decision of Substantially Equivalent on March 20, 2014. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Maquet Critical Care AB has at least 10 other 510(k) clearances on record.