510(k) K210906 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
| Applicant | Philips Medizin Systeme Boeblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Oct 7, 2021 |
| Received | Mar 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210906
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX750. Product Number: 866471. Open, Classified |
MHX | None listed |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX850. Product Number: 866470. Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.