510(k) K883331 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 26, 1988 |
| Received | Aug 8, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883331
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.