510(k) K153162 ยท NCX System, Hypothermia, Intravenous, Cooling
Hypocore
| Applicant | Novocor Medical Systems, Inc., Durham NC, US |
| Decision | Substantially Equivalent, May 24, 2016 |
| Received | Nov 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153162
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.