510(k) K012512 ยท NCX System, Hypothermia, Intravenous, Cooling
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
| Applicant | Radiant Medical, Redwood City CA, US |
| Decision | Substantially Equivalent, Jun 11, 2002 |
| Received | Aug 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012512
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.