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IntelliVue Patient Monitor MX750

by Philips Medizin Systeme Böblingen GmbH

Ref 866471

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK251702 Date10 Nov 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number0884838BM591TG Basic UDI-DI 00884838083332UDI-DIDate15 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838083332 UDI-DI Date29 Nov 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0870-2026 FDA Class II initiated 31 Oct 2025
    • Ongoing Z-0868-2026 FDA Class II initiated 31 Oct 2025

    Potential issue where the IntelliVue monitors did not alarm.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Multiple vital physiological parameter monitoring system, clinical
Model / Ref / Catalog
866471, IntelliVue Patient Monitor MX750
Primary DI / UDI-DI
00884838083332
Basic UDI-DI
0884838BM591TG
Direct Marketing DI
00884838083332
FDA Product Code
MHX
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
GMDN Term
Multiple vital physiological parameter monitoring system, clinical
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
866471
GUDID
IntelliVue Patient Monitor MX750
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IntelliVue Patient Monitor MX750/850 is a Class IIb medical device classified under nomenclature code Z1203020201, designed for continuous patient monitoring in clinical settings. It provides real-time measurement and display of vital signs, including physiological parameters such as ECG, blood pressure, pulse oximetry, and respiratory rate, enabling clinicians to assess patient status and respond to changes promptly.

This device is intended for single-use applications in hospital environments, though it is not sterile or implantable. Supplied as a non-reusable unit, it operates within standard regulatory frameworks, including FDA 510(k) and MDR compliance. The monitor is equipped with a unique Device Identifier (DI) and UDI data for traceability, ensuring adherence to global medical device standards. Storage and handling follow manufacturer guidelines to maintain functionality and safety.

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No