510(k) K854045 ยท DTZ Oxygenator, Cardiopulmonary Bypass
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
| Applicant | American Bentley, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 16, 1985 |
| Received | Oct 2, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854045
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.