510(k) K181311 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips Hemodynamic Application R1.0
| Applicant | Philips Medical Systems Nederlands B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Sep 7, 2018 |
| Received | May 17, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K181311
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases. Open, Classified |
MWI | None listed |
| Feb 22, 2022 | Philips North America Llc Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.