FDA 510(k)

IntelliVue Capnography Extension, IntelliVue Microstream Extension

Número K: K172904 · 2017-12-26

RequerentePhilips Medizin Systeme Boeblingen GmbH

Data da decisão2017-12-26

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

IntelliVue Capnography Extension, 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 2017-12-26 under 510(k) number K172904. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IntelliVue Capnography Extension, IntelliVue Microstream Extension?

IntelliVue Capnography Extension, IntelliVue Microstream Extension is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K172904.

When did IntelliVue Capnography Extension, IntelliVue Microstream Extension receive FDA 510(k) clearance?

IntelliVue Capnography Extension, IntelliVue Microstream Extension received FDA 510(k) clearance on 2017-12-26, under 510(k) number K172904.

Who is the listed applicant for IntelliVue Capnography Extension, 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 Capnography Extension, IntelliVue Microstream Extension?

The FDA product code for IntelliVue Capnography Extension, IntelliVue Microstream Extension is CCK.

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Outros registros que listam Philips Medizin Systeme Boeblingen GmbH como candidato(a)

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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Fonte oficial

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