IntelliVue Multi-Measurement Module X3 (867030) +2 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252726 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
- Models / Variants
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 Multi-Measurement Module X3 (867030), IntelliVue Patient Monitor MX100 (867033), and IntelliVue MMX (867036) are physiological patient monitors designed for continuous monitoring of vital signs. These devices incorporate arrhythmia detection and alarm capabilities, enabling real-time assessment of cardiac and respiratory parameters in clinical settings. They are classified as Class II medical devices under FDA regulations and fall under the cardiovascular specialty category.
These monitors are intended for use in hospital, critical care, and emergency settings, providing essential patient monitoring for arrhythmias and other physiological parameters. Supplied as reusable devices, they undergo regulatory compliance under the FDA’s 510(k) pathway, the EU’s Medical Device Directive (MDD), and the Medical Device Regulation (MDR). Each model is assigned specific reference codes for identification, ensuring traceability and adherence to global regulatory standards. Storage and handling follow manufacturer guidelines to maintain device integrity and performance.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252726 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K252726 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026