Identifiers
- 510(k) Number
- K180017 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 Release C.01 is a battery-operated, wearable multi-parameter patient monitor designed for physiological monitoring. It acquires and displays real-time data including electrocardiogram (ECG), respiration, pulse oximetry (SpO₂), and non-invasive blood pressure (NIBP), supporting ambulatory and transport patient care in clinical settings.
This device is intended for single-use or reusable applications in hospital environments and during patient transport. It features wireless connectivity via multi-radio design (802.11a/b/g/h, 1.4GHz, 2.4GHz short-range radio) for integration with Philips telemetry networks and IntelliVue monitors. The MX40 Release C.01 holds an FDA 510(k) clearance under the classification of Class II medical devices (MHX product code) and adheres to regulatory requirements under 870.1025.
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 tragbarer Patientenmonitor | Philips - Philips, MX40 Release C.01 (K180017) — FDA 510 (k) | Innolitics, PDF 867146 MX40 IFU - documents.philips.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180017 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (1)
- FDA 510(k) K180017 24 fields · synced Sep 19, 2026