IntelliVue Patient Monitor MX450

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 866062

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name: IntelliVue Patient Monitor MX450 EUDAMED
IntelliVue MX450 Patient Monitor FDA UDI
Generic Name: Multiple vital physiological parameter monitoring system, clinical FDA UDI
Device Name: MX400-550 EUDAMED
The IntelliVue MX450 patient monitor is operated primarily via touch screen. It has an integrated 12" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/ IntelliVue MMX (867036)/ IntelliVue X3 (867030). The IntelliVue MX450 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor easily portable. FDA UDI
Model / Reference: 866062 EUDAMED
IntelliVue Patient Monitor MX450 FDA UDI
Description: The IntelliVue MX450 patient monitor is operated primarily via touch screen. It has an integrated 12" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/ IntelliVue MMX (867036)/ IntelliVue X3 (867030). The IntelliVue MX450 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor easily portable. FDA UDI

Identifiers

Catalog Number: 866062 FDA UDI
Primary DI / UDI-DI: 00884838038769 EUDAMEDFDA UDI
Basic UDI-DI: 0884838BM589TV EUDAMED
Direct Marketing DI: 00884838038769 EUDAMED
FDA Product Code: MHX FDA UDI
EMDN Code: Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
GMDN Term: Multiple vital physiological parameter monitoring system, clinical FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 870.1025 FDA UDI
Market of Registration: Austria EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

The IntelliVue Patient Monitor MX450, manufactured by Philips Medizin Systeme Böblingen GmbH, is a medical device designed for patient monitoring. It features a measuring function to provide clinical data for patient assessment.

This device is classified as Class IIb and is not intended for implantation. It is supplied as a non-sterile, reusable unit and is subject to FDA 510K and MDR regulatory authorizations. The monitor is identified by reference number 866062 and Basic UDI 0884838BM589TV.

Frequently asked questions

Is the IntelliVue Patient Monitor MX450 sterile?

No, the device is not sterile. It is designed for clinical use in a non-sterile state.

Can the MX450 monitor be implanted in a patient?

No, the device is not implantable. It is intended for external patient monitoring purposes only.

What is the regulatory classification of this monitor?

The IntelliVue Patient Monitor MX450 is classified as a Class IIb medical device and holds both FDA 510K and MDR authorizations.

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 Patient Monitor - MX400/MX450/MX500/MX550, philips - accessdata.fda.gov, Philips Medizin Systeme Böblingen GmbH - RevMed, IntelliVue MX450 Portable/bedside patient monitor - Philips, DEVICE: IntelliVue MX450 Patient Monitor (00884838038769)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K122439	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K141015	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K113657	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K223574	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K151681	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K150310	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K130849	Class IIb	Active
EUDAMED	European Union	CE/MDR	0884838BM589TV	Class IIb	Active

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Manufacturer

Manufacturer: Philips Medizin Systeme Böblingen GmbH
EUDAMED SRN: DE-MF-000006026

Sources (3)

EUDAMED 26153402-72ca-44f6-b990-37ff5566df77 61 fields · synced Oct 6, 2026
FDA UDI f36fbc08-2d50-42d4-8ec9-c302f501d3d7 36 fields · synced May 30, 2026
FDA 510(k) K122439 1 fields · synced May 18, 2026