510(k) K192169 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
PulsioFlex Monitoring System with ProAQT Sensor
| Applicant | Pulsion Medical Systems SE, Feldkirchen, DE |
| Decision | Substantially Equivalent, Apr 30, 2020 |
| Received | Aug 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192169
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.