510(k) K163337

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2017
Date Received
November 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type