Intellivue MX40 Patient Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103646 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 Mx40 Patient Monitor is a physiological patient monitor with arrhythmia detection or alarms, classified as a Class II medical device under FDA regulation 870.1025 and product code MHX. It is designed for cardiovascular monitoring and has been determined to be substantially equivalent to a legally marketed device through the FDA 510(k) clearance process.
The device is manufactured by Phillips Medical Systems and was cleared under K103646 on January 7, 2011, following receipt on December 14, 2010. It is intended for use in clinical settings to monitor patient physiological parameters, including ECG, and may support optional SpO2 and impedance respiration monitoring via cableless measurements, as indicated by its wearable design for ambulatory patients.
Frequently asked questions
What is the Intellivue MX40 Patient Monitor used for?
The Intellivue MX40 Patient Monitor is designed for cardiovascular monitoring in clinical settings, tracking physiological parameters such as ECG, and may support optional SpO2 and impedance respiration monitoring via cableless measurements for ambulatory patients, as indicated by its wearable design.
How is the Intellivue MX40 Patient Monitor supplied or configured for use?
The device is supplied as a wearable physiological patient monitor intended for ambulatory use, enabling cableless measurements of parameters like SpO2 and respiration, and is designed to be used in clinical environments for continuous patient monitoring.
Is the Intellivue MX40 Patient Monitor a single-use or reusable device?
The Intellivue MX40 Patient Monitor is a reusable device designed for multiple clinical uses; it is not intended as a single-use product, as it is a physiological monitor built for ongoing operation in healthcare settings with detachable sensors and cables.
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: IntelliVue MX40 Patient Wearable Monitor | Philips - Philips, IntelliVue MX40 Patient Wearable Monitor, 2.4 GHz Smart Hopping | Philips, Philips Healthcare | IntelliVue MX40 Patient Wearable Monitor, Philips IntelliVue MX40 Wearable Patient Monitor - Soma Tech Intl
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103646 | Class II | Active |
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Manufacturer
- Manufacturer
- Phillips Medical Systems
Sources (1)
- FDA 510(k) K103646 24 fields · synced Oct 6, 2026