510(k) K031223 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, May 2, 2003 |
| Received | Apr 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031223
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.