INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5— 510(k) K082583
Substantially EquivalentPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
FDA 510(k) clearance K082583 for INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5, Substantially Equivalent on 2009-02-25. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. Device class: 2.
Clearance details
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boeblingen, Baden-Wuerttemberg, DE
Recent devices under product code MHX
view allMore clearances from Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
view all- K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
- K132320 — INTELLIVUE CL RESPIRATION POD
- K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
- K131829 — INTELLIVUE PATIENT MONITOR
- K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K082583
K-number listed on FDA's recall record- Z-1106-2025 — IntelliBridge EC10 Module. Model Number: 865115
- Z-1107-2025 — IntelliVue Patient Monitor MX400. Model Number: 866060
- Z-1108-2025 — IntelliVue Patient Monitor MX450. Model Number: 866062
- Z-1109-2025 — IntelliVue Patient Monitor MX500. Model Number: 866064
- Z-1110-2025 — IntelliVue Patient Monitor MX550. Model Number: 866066
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082583.
Data sourced from openFDA. This site is unofficial and independent of the FDA.