510(k) K250922 ยท DSB Plethysmograph, Impedance
Edema Guard Monitor (EGM) CardioSet-001
| Applicant | Cardioset Medical , Ltd., Matan, IL |
| Decision | Substantially Equivalent, Sep 9, 2025 |
| Received | Mar 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250922
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.