510(k) K162413 ยท MLR Sterilizer, Chemical
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Mar 31, 2017 |
| Received | Aug 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2018 | Steris Corporation V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.