510(k) K893940 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
POLYSTAN HEATER-COOLER UNIT
| Applicant | Polystan C/O Vitalcor, Inc., Denmark, DK |
| Decision | Substantially Equivalent, Jan 18, 1990 |
| Received | May 31, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893940
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.