510(k) K250453 · MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
| Applicant | Philips Medizin Systeme Böblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Sep 2, 2025 |
| Received | Feb 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250453
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.