510(k) K260343 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Carescape Canvas 1000; Carescape Canvas Smart Display
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Aug 28, 2026 |
| Received | Feb 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260343
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.