510(k) K201984 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MPS 3 ND Myocardial Protection System
| Applicant | Quest Medical, Inc., Allen TX, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Jul 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201984
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.