510(k) K160665

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 by Maquet Critical Care AB — Product Code BSZ

K160665 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40". The FDA issued a decision of Substantially Equivalent on March 29, 2017. 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.