510(k) K150489 ยท DTZ Oxygenator, Cardiopulmonary Bypass
EOS PMP, EOS PMP Integrated
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jun 11, 2015 |
| Received | Feb 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150489
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.