510(k) K830639 ยท DTZ Oxygenator, Cardiopulmonary Bypass
HI FLEX D-700 MODULAR BUBBLE OXYGENA-
| Applicant | Electromedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 25, 1983 |
| Received | Mar 1, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830639
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.