510(k) K230881 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Change Healthcare Cardiology Hemodynamics
| Applicant | Change Healthcare Israel , Ltd., Holon, IL |
| Decision | Substantially Equivalent, Sep 11, 2023 |
| Received | Mar 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Cardiology Hemodynamics Software Open, Classified |
MWI | None listed |
| Jan 16, 2025 | A L I Technologies Ltd Change Healthcare Cardiology Hemodynamics software Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.