510(k) K831677 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
HYPER-HYPOTHERMIA UNIT HYPO 10-200
| Applicant | Gambro, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 18, 1983 |
| Received | May 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831677
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.