FDA 510(k)

Philips Hemodynamic Application R1.0

Número K: K181311 · 2018-09-07

RequerentePhilips Medical Systems Nederlands B.V.

Data da decisão2018-09-07

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips Hemodynamic Application R1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181311. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips Hemodynamic Application R1.0?

Philips Hemodynamic Application R1.0 is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K181311.

When did Philips Hemodynamic Application R1.0 receive FDA 510(k) clearance?

Philips Hemodynamic Application R1.0 received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181311.

Who is the listed applicant for Philips Hemodynamic Application R1.0?

The FDA 510(k) record lists Philips Medical Systems Nederlands B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Hemodynamic Application R1.0?

The FDA product code for Philips Hemodynamic Application R1.0 is MWI.

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Fonte oficial

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