510(k) K081221 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
| Applicant | Levitronix, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Jun 19, 2008 |
| Received | Apr 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081221
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.