510(k) K222093

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System by Steris — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2022
Date Received
July 15, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type