510(k) K191027

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System by Maquet Critical Care AB — Product Code BSZ

K191027 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System". The FDA issued a decision of Substantially Equivalent on March 18, 2020. 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.