510(k) K801240 ยท DTZ Oxygenator, Cardiopulmonary Bypass
BUILT-IN TEMPERATURE MONITORING
| Applicant | Bentley Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 4, 1980 |
| Received | May 27, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801240
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.