INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450— 510(k) K130849
Substantially EquivalentPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
FDA 510(k) clearance K130849 for INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450, Substantially Equivalent on 2013-06-14. 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
- K120366 — INTELLIVUE PATIENT MONITOR
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 K130849
K-number listed on FDA's recall record- Z-0862-2026 — IntelliVue Patient Monitor MX400. Product Number: 866060.
- Z-0863-2026 — IntelliVue Patient Monitor MX450. Product Number: 866062.
- Z-3249-2024 — IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
- Z-2508-2024 — IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
- Z-2509-2024 — IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
- Z-2510-2024 — IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
- Z-2511-2024 — IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
- Z-0020-2025 — IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130849.
Data sourced from openFDA. This site is unofficial and independent of the FDA.