510(k) K260656 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Sep 1, 2026 |
| Received | Feb 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260656
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.