510(k) K182862

Servo Guard by Maquet Critical Care AB — Product Code CAH

K182862 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "Servo Guard". The FDA issued a decision of Substantially Equivalent on October 21, 2019. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Maquet Critical Care AB has at least 10 other 510(k) clearances on record.