510(k) K253277 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253277
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.