510(k) K182110 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
CDI Blood Parameter Monitoring System 550
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Aug 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182110
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.