FDA 510(k)

IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension

N.º K: K181314 · 2018-09-04

SolicitantePhilips Medizin Systeme Boeblingen GmbH

Fecha de decisión2018-09-04

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension 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 2018-09-04 under 510(k) number K181314. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension?

IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension is a medical device that received FDA 510(k) clearance on 2018-09-04. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K181314.

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

IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension received FDA 510(k) clearance on 2018-09-04, under 510(k) number K181314.

Who is the listed applicant for IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension?

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, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension?

The FDA product code for IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension is MHX.

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Otros registros que enlistan a Philips Medizin Systeme Boeblingen GmbH como solicitante

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)K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)

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Fuente oficial

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