510(k) K232048 · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cogent Hemodynamic Monitoring System; Cogent HMS
| Applicant | Icu Medical, San Clemente CA, US |
| Decision | Substantially Equivalent, Dec 20, 2023 |
| Received | Jul 10, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232048
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.