510(k) K063829 ยท NCX System, Hypothermia, Intravenous, Cooling
THERMOGARD THERMAL REGULATION SYSTEM
| Applicant | Alsius Corp., Irvine CA, US |
| Decision | Unknown, Jan 22, 2007 |
| Received | Dec 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063829
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.