510(k) K082583 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Feb 25, 2009 |
| Received | Sep 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | Philips North America Llc IntelliBridge EC10 Module. Model Number: 865115 Open, Classified |
MHX | None listed |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX400. Model Number: 866060 Open, Classified |
MHX | None listed |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX450. Model Number: 866062 Open, Classified |
MHX | None listed |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX500. Model Number: 866064 Open, Classified |
MHX | None listed |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX550. Model Number: 866066 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.