INTELLIVUE PATIENT MONITOR - Mx800

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K102562

by Philips Medizin Systeme Böblingen GmbH

Identifiers

510(k) Number: K102562 FDA 510(k)
FDA Product Code: MHX FDA 510(k)
Models / Variants: Mp2 FDA 510(k)EUDAMED
X2 FDA 510(k)EUDAMED
Mp5 FDA 510(k)EUDAMED
Mp5t FDA 510(k)EUDAMED
Mp20 FDA 510(k)EUDAMED
Mp30 FDA 510(k)EUDAMED
Mp40 FDA 510(k)EUDAMED
Mp50 FDA 510(k)EUDAMED
Mp60 FDA 510(k)EUDAMED
Mp70 FDA 510(k)EUDAMED
Mp80 FDA 510(k)EUDAMED
Mp90 FDA 510(k)EUDAMED
Mx800 FDA 510(k)EUDAMED

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 Patient Monitor is a physiological patient monitoring device designed for continuous assessment of vital signs. It detects arrhythmias and provides alarms to alert clinicians to potential cardiac or respiratory abnormalities, supporting real-time patient care in clinical settings.

These monitors are intended for use in hospital wards, intensive care units, and emergency departments, where they are connected to patients via electrodes and sensors. Supplied as reusable medical devices, they comply with FDA 510(k) clearance, MDD, and MDR regulations. Each model varies in functionality and display capabilities, ensuring compatibility with diverse clinical workflows.

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

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K102562	Class II	Active

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Manufacturer

Manufacturer: Philips Medizin Systeme Böblingen GmbH
FDA Applicant: Philips Medizin Systeme Boblingen GmbH

Sources (2)

FDA 510(k) K102562 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026