510(k) K172259 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
PulsioFlex Monitoring System
| Applicant | Pulsion Medical Systems SE, Feldkirchen, DE |
| Decision | Substantially Equivalent, Jan 18, 2018 |
| Received | Jul 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172259
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2019 | GETINGE US SALES LLC PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0.
Usage:
The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monit Terminated |
DXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.