510(k) K191896

Belimed Steam Sterilizer MST-H TOP 5000 by Belimed AG — Product Code FLE

K191896 is an FDA 510(k) premarket notification submitted by Belimed AG for the device "Belimed Steam Sterilizer MST-H TOP 5000". The FDA issued a decision of Substantially Equivalent on October 31, 2019. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Belimed AG has at least 2 other 510(k) clearances on record.