Decision Date2025-10-17
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
IntelliVue Patient monitors MX400, MX450, MX500, MX550 is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2025-10-17 under approval number K251146. 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 MX400, MX450, MX500, MX550?
IntelliVue Patient monitors MX400, MX450, MX500, MX550 is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K251146.
When was IntelliVue Patient monitors MX400, MX450, MX500, MX550 approved by the FDA?
IntelliVue Patient monitors MX400, MX450, MX500, MX550 received FDA 510(k) clearance on 2025-10-17, under approval number K251146.
What company makes IntelliVue Patient monitors MX400, MX450, MX500, MX550?
IntelliVue Patient monitors MX400, MX450, MX500, MX550 is manufactured by Philips Medizin Systeme Boeblingen GmbH.
What is the FDA product code for IntelliVue Patient monitors MX400, MX450, MX500, MX550?
The FDA product code for IntelliVue Patient monitors MX400, MX450, MX500, MX550 is MHX.
Related PubMed Literature
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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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.