510(k) K851035 ยท DTZ Oxygenator, Cardiopulmonary Bypass
AMERICAN BENTLEY OXYGENATOR MAX-2
| Applicant | American Bentley, Irvine CA, US |
| Decision | Substantially Equivalent, May 16, 1985 |
| Received | Mar 13, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851035
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.