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FDA 510(k)

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3

K-Number: K182979 · 2019-11-19

ApplicantPhilips Medizin Systeme Boeblingen GmbH
Decision Date2019-11-19
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2019-11-19 under approval number K182979. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3?

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 is a medical device that received FDA 510(k) clearance on 2019-11-19. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K182979.

When was IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 approved by the FDA?

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 received FDA 510(k) clearance on 2019-11-19, under approval number K182979.

What company makes IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3?

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3?

The FDA product code for IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 is MHX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41103840 The Essential Role of Medical Monitors in Clinical Trials. Cureus (2025) PMID: 40794850 Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices. The journal of applied laboratory medicine (2025)

Other Devices by Philips Medizin Systeme Boeblingen GmbH

K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 K172904IntelliVue Capnography Extension, IntelliVue Microstream Extension K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable K161767Philips IntelliVue GuardianSoftware K181831IntelliVue Multi-Measurement Module MMX K173941IntelliSpace Perinatal Rev.K.00

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Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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