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INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE - MP60

by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

510(k) K082583

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082583↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK082583 Date25 Feb 2009ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1109-2025 FDA Class II initiated 15 Jan 2025
    • Ongoing Z-1108-2025 FDA Class II initiated 15 Jan 2025
    • Ongoing Z-1107-2025 FDA Class II initiated 15 Jan 2025
    • Ongoing Z-1106-2025 FDA Class II initiated 15 Jan 2025
    • Ongoing Z-1110-2025 FDA Class II initiated 15 Jan 2025

    Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MHX
Models / Variants
MP60
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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 is a physiological patient monitoring device designed to measure and display multiple vital signs, including arrhythmia detection and alarms. It falls under the category of a patient monitor with arrhythmia detection or alarms, as classified by regulatory authorities. The device is intended for continuous monitoring of adult, pediatric, and neonatal patients in hospital settings, providing real-time data and alerts for critical parameters.

The IntelliVue Patient Monitor, including the IntelliBridge Module, is supplied as a reusable medical device and is intended for use in clinical environments. It has received FDA 510(k) clearance and complies with the Medical Devices Directive (MDD). The models MP40, MP50, MP60, MP70, MP80, MP90, EC10, and EC5 are part of this product line, each designed for integration into hospital monitoring systems. No specific sterility or MRI safety information is provided in the data.

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Questions

AI-generated answers, 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.

  • What patient populations is the IntelliVue Patient Monitor designed to monitor, and where is it typically used?

    The IntelliVue Patient Monitor is designed for continuous monitoring of adult, pediatric, and neonatal patients in hospital settings. It provides real-time tracking of vital signs and arrhythmia detection with alarms, making it suitable for critical care environments like ICUs, emergency rooms, and operating rooms.

  • How are the IntelliVue Patient Monitor and its IntelliBridge Module supplied, and are they single-use or reusable?

    The IntelliVue Patient Monitor, including the IntelliBridge Module, is supplied as a reusable medical device for clinical use. Unlike disposable monitors, it is intended for repeated use in hospital environments, requiring proper cleaning and maintenance between patients.

  • What models are available for the IntelliVue Patient Monitor, and how do they differ in terms of regulatory compliance?

    The IntelliVue Patient Monitor includes multiple models: MP40, MP50, MP60, MP70, MP80, MP90, EC10, and EC5. All models are FDA 510(k)-cleared and comply with the Medical Devices Directive (MDD), but specific features or configurations may vary by model. The regulatory route remains consistent across the line, as they fall under the same classification for physiological patient monitoring with arrhythmia detection.

  • Is sterility or MRI safety information provided for the IntelliVue Patient Monitor, and what should clinicians consider regarding its use?

    The provided data does not specify sterility requirements for the IntelliVue Patient Monitor or its IntelliBridge Module, meaning clinicians must follow hospital protocols for cleaning and disinfection. Additionally, no MRI safety information is mentioned, so its use near MRI machines should be evaluated based on hospital policies to avoid interference or safety risks.