510(k) K922933 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
| Applicant | Sorin Biomedica, Fiat, USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 30, 1992 |
| Received | Jun 18, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922933
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.