510(k) K813034 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
POLYSTAN HEART LUNG MACHINE SYS
| Applicant | Advocacy International, Ltd., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 27, 1981 |
| Received | Oct 28, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813034
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.