510(k) K102109 ยท DTZ Oxygenator, Cardiopulmonary Bypass
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
| Applicant | Eurosets S.R.L, Medolla, Modena, IT |
| Decision | Substantially Equivalent, Feb 15, 2011 |
| Received | Jul 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102109
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.