510(k) K182568
K182568 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System". The FDA issued a decision of Substantially Equivalent on January 3, 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
- January 3, 2019
- Date Received
- September 18, 2018
- Clearance Type
- Traditional
- 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