510(k) K190103
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System by
STERIS Corporation
— Product Code MLR
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2019
- Date Received
- January 22, 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