510(k) K964332 ยท FLE Sterilizer, Steam
EAGLE CENTURY STEAM STERILIZER
| Applicant | Amsco Intl., Inc., Erie PA, US |
| Decision | Substantially Equivalent, Jun 1, 1998 |
| Received | Oct 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964332
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2019 | Steris Corporation Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two Terminated |
FLE | None listed |
| Sep 17, 2008 | Steris Corp Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat Terminated |
FLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.