FDA 510(k)

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550

K-Number: K192137 · 2020-09-11

ApplicantPhilips Medizin Systeme Boeblingen GmbH

Decision Date2020-09-11

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2020-09-11 under approval number K192137. 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 Monitor MX500, IntelliVue Patient Monitor MX550?

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K192137.

When was IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 approved by the FDA?

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 received FDA 510(k) clearance on 2020-09-11, under approval number K192137.

What company makes IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550?

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550?

The FDA product code for IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 is MHX.

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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

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