510(k) K812093 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
COBE HEAT EXCHANGER RESERVOIR MODULE
| Applicant | Cobe Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 13, 1981 |
| Received | Jul 24, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812093
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.