510(k) K033623 ยท NCX System, Hypothermia, Intravenous, Cooling
CELSIUS CONTROL SYSTEM
| Applicant | Innercool Therapies, Inc., San Diego, CA, US |
| Decision | Substantially Equivalent, May 21, 2004 |
| Received | Nov 18, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033623
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.