IntelliVue MP5 Patient Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083228 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IntelliVue MP5 Patient Monitor is a physiological patient monitoring device designed for continuous, non-invasive assessment of vital signs. It detects and alarms for arrhythmias, providing real-time monitoring of heart rate, rhythm, blood pressure, oxygen saturation, and other critical parameters to support clinical decision-making in acute and critical care settings.
This device is intended for use in hospital environments, including intensive care units, emergency departments, and operating rooms. Supplied as a reusable medical instrument, it requires proper cleaning, disinfection, and maintenance between patient uses. The IntelliVue MP5 adheres to FDA 510(k) and MDD regulatory standards, with a classification as a Class II medical device. No specific MRI safety information is provided in the available data.
Frequently asked questions
What clinical settings is the Philips IntelliVue MP5 Patient Monitor designed for and what key features does it provide?
The Philips IntelliVue MP5 Patient Monitor is specifically designed for use in acute and critical care environments, including intensive care units (ICUs), emergency departments, and operating rooms. It continuously monitors vital signs such as heart rate, rhythm, blood pressure, and oxygen saturation, while also detecting and alarming for arrhythmias to support real-time clinical decision-making.
Is the Philips IntelliVue MP5 Patient Monitor intended for single-use or reusable applications, and what maintenance is required?
The Philips IntelliVue MP5 Patient Monitor is supplied as a reusable medical instrument. Between patient uses, it requires proper cleaning, disinfection, and maintenance to ensure safety and functionality, as outlined in the manufacturer’s guidelines.
What regulatory pathways has the Philips IntelliVue MP5 Patient Monitor followed, and what classification does it hold?
The Philips IntelliVue MP5 Patient Monitor has been authorized through the FDA 510(k) pathway and adheres to the Medical Device Directive (MDD) in Europe. It is classified as a Class II medical device, indicating a moderate risk level requiring additional regulatory oversight.
Does the Philips IntelliVue MP5 Patient Monitor have any specific MRI safety information provided?
The available data for the Philips IntelliVue MP5 Patient Monitor does not include any specific MRI safety information, meaning its compatibility or safety in MRI environments is not detailed in the provided documentation.
What types of monitoring capabilities does the Philips IntelliVue MP5 Patient Monitor support, and how does it assist clinicians?
The Philips IntelliVue MP5 Patient Monitor supports continuous, non-invasive monitoring of critical physiological parameters, including heart rate, rhythm (with arrhythmia detection), blood pressure, and oxygen saturation. Its alarming system for arrhythmias helps clinicians quickly identify and respond to potential cardiac issues, improving patient safety and decision-making in high-stakes environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Global home | Philips, Philips Deutschland – Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K083228 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- FDA Applicant
- Philips Medizin Systeme Boblingen GmbH
Sources (2)
- FDA 510(k) K083228 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026