IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230604 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 Patient Monitor MX100 (867033) and IntelliVue Multi-Measurement Module X3 (867030) are physiological patient monitors designed for continuous, multi-parameter monitoring of adults, pediatrics, and neonates. These devices measure and display vital signs such as ECG, blood pressure, pulse oximetry, respiratory rate, and temperature, while also providing arrhythmia detection and alarm capabilities. They fall under the classification of Class II medical devices and are intended for use in clinical settings requiring real-time patient assessment.
The monitors are portable, battery-powered devices featuring a 15.5 cm (6.1 inch) touchscreen for intuitive operation. They are supplied as standalone units or as modular components, intended for use in both inpatient and mobile care environments. The devices are regulated under FDA 510(k) clearance and MDR, with a product code classification of MHX. They are not specified as single-use or reusable, and no MRI safety information is provided in the data.
Frequently asked questions
What patient populations can the IntelliVue Patient Monitor MX100 be used for, and how does this differ from the Multi-Measurement Module X3?
The IntelliVue Patient Monitor MX100 (867033) is designed for continuous, multi-parameter monitoring of adults, pediatrics, and neonates, covering all age groups. The IntelliVue Multi-Measurement Module X3 (867030) is a modular component intended to expand monitoring capabilities of an existing IntelliVue system, rather than a standalone device. Both share the same vital sign measurements (ECG, blood pressure, pulse oximetry, respiratory rate, temperature, and arrhythmia detection), but the X3 is meant for integration into an existing setup rather than standalone use.
Are the IntelliVue MX100 and Multi-Measurement Module X3 portable, and if so, how does this affect their use in clinical settings?
Yes, both devices are portable and battery-powered, making them ideal for mobile care environments as well as inpatient settings. Their portability allows for real-time patient monitoring during transfers, in emergency departments, or on medical floors where flexibility is required. The 15.5 cm touchscreen also enhances usability in dynamic clinical settings.
How is the sterility and reuse status of the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 specified?
The provided data does not specify whether the IntelliVue Patient Monitor MX100 or the Multi-Measurement Module X3 are single-use or reusable. Since no sterility claims or reuse instructions are mentioned, users should refer to Philips’ official guidelines or instructions for use for proper handling and cleaning protocols. This omission suggests the devices may be intended for reusable clinical environments but requires confirmation from the manufacturer.
What regulatory pathways have the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 followed, and how does this impact their use?
The devices are regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a product code classification of MHX (Monitor, Physiological). Their substantial equivalence determination (SESE) under the FDA’s traditional pathway and classification as Class II devices indicate they meet established safety and performance standards. This ensures compliance with stringent regulatory requirements for continuous patient monitoring in clinical settings.
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 MX100 patient monitor | Philips - Philips, PDF IntelliVue Patient Monitor - Philips, IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230604 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K230604 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026