510(k) K102129 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
| Applicant | Levitronix, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Aug 27, 2010 |
| Received | Jul 29, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102129
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.