510(k) K140012 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
SORIN FLEXTHERM
| Applicant | Sorin Group Deutschland GmbH, Arvada CO, US |
| Decision | Substantially Equivalent, Jan 31, 2014 |
| Received | Jan 2, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140012
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.