510(k) K163337

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer by Midmark Corporation — Product Code FLE

K163337 is an FDA 510(k) premarket notification submitted by Midmark Corporation for the device "Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer". The FDA issued a decision of Substantially Equivalent on August 31, 2017. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Midmark Corporation has at least 5 other 510(k) clearances on record.