← Back to catalogue

Philips Intellivue Patient Monitor, Models Mp40 & Mp50

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040304

by Philips Medizin Systeme Boeblingen GmbH

Identifiers

510(k) Number
K040304 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 Philips Intellvue Patient Monitor, Models MP40 & MP50 is a physiological patient monitor with arrhythmia detection or alarms, classified as a Class II device under FDA regulation 870.1025. It is designed for monitoring patient physiological parameters and detecting arrhythmias, as indicated by its device name and classification.

The device received FDA 510(k) clearance (K040304) on March 1, 2004, and was found substantially equivalent to a predicate device. It is manufactured by Philips Medizin Systeme Boeblingen GmbH and is intended for use in intermediate care environments, offering portability, measurement flexibility, and a modular design with a common user interface across the Intellvue product line.

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 MP40 and MP50 Bedside patient monitors - Philips, PDF IntelliVue MP40/MP50 Patient Monitor, PDF IntelliVue Patient Monitor - documents.philips.com, PDF IntelliVue Patient Monitor - Philips

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Philips Medizin Systeme Boeblingen GmbH

Sources (1)

  • FDA 510(k) K040304 24 fields · synced Oct 6, 2026