510(k) K063405 ยท NCX System, Hypothermia, Intravenous, Cooling
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
| Applicant | Radiant Medical, Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 8, 2007 |
| Received | Nov 9, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063405
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.