510(k) K190917

V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems by STERIS Corporation — Product Code MLR

K190917 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems". The FDA issued a decision of Substantially Equivalent on May 9, 2019. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2019
Date Received
April 9, 2019
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