510(k) K152946 ยท NCX System, Hypothermia, Intravenous, Cooling
TEMPEDY
| Applicant | Seiratherm GmbH, 91074 Herzogenaurach, DE |
| Decision | Substantially Equivalent, Sep 15, 2016 |
| Received | Oct 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152946
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.