510(k) K201927

Getinge GSS610N Series Steam Sterilizer by Maquet GmbH — Product Code FLE

K201927 is an FDA 510(k) premarket notification submitted by Maquet GmbH for the device "Getinge GSS610N Series Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on March 1, 2021. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Maquet GmbH has at least 6 other 510(k) clearances on record.