510(k) K850630 ยท DTZ Oxygenator, Cardiopulmonary Bypass
BLOOD OXYGENATOR MODEL NO. MAX-5
| Applicant | American Bentley, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 27, 1985 |
| Received | Feb 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850630
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.