510(k) K123039 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
CDI BLOOD PARAMETER MONITORING SYSTEM 500
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 20, 2012 |
| Received | Sep 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123039
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.