510(k) K090450 ยท DTZ Oxygenator, Cardiopulmonary Bypass
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
| Applicant | Gish Biomedical, Inc., Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, Sep 18, 2009 |
| Received | Feb 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090450
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.