510(k) K091950 ยท FRC Indicator, Biological Sterilization Process
SMART-WELL EZTEST INCUBATOR
| Applicant | Sgm Biotech, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, Jan 15, 2010 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091950
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.