510(k) K931967 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
HE-30 GOLD
| Applicant | Bentley Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 13, 1993 |
| Received | Apr 21, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931967
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.