510(k) K843983 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MYOCARDIAL INSULATOR
| Applicant | Norton Texas Medical Products, Houston TX, US |
| Decision | Substantially Equivalent, Dec 27, 1984 |
| Received | Oct 11, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843983
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.