FDA 510(k)

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

Numéro K : K230604 · 2023-11-22

DemandeurPhilips Medizin Systeme Boeblingen GmbH

Date de décision2023-11-22

Code produitMHX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K230604. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K230604.

When did IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) receive FDA 510(k) clearance?

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) received FDA 510(k) clearance on 2023-11-22, under 510(k) number K230604.

Who is the listed applicant for IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

The FDA 510(k) record lists Philips Medizin Systeme Boeblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

The FDA product code for IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) is MHX.

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Autres dossiers indiquant Philips Medizin Systeme Boeblingen GmbH en tant que demandeur

K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550 K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4

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Source officielle

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