510(k) K900186 ยท DWJ System, Thermal Regulating
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 10, 1990 |
| Received | Jan 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900186
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.