510(k) K211495 ยท DTZ Oxygenator, Cardiopulmonary Bypass
EOS PMP
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jul 12, 2021 |
| Received | May 13, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211495
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.