ClearanceBrief
510(k) K251146 · MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

IntelliVue Patient monitors MX400, MX450, MX500, MX550

ApplicantPhilips Medizin Systeme Boeblingen GmbH, Böblingen, DE
DecisionSubstantially Equivalent, Oct 17, 2025
ReceivedApr 14, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251146

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.