FDA 510(k)

Sistema Aquadex FlexFlow 2.0

Número K: K192756 · 2020-02-24

Data da decisão2020-02-24

Código do produtoKDI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aquadex FlexFlow System 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Chf Solutions, Inc.. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K192756. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aquadex FlexFlow System 2.0?

Aquadex FlexFlow System 2.0 is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is Chf Solutions, Inc.. The 510(k) number is K192756.

When did Aquadex FlexFlow System 2.0 receive FDA 510(k) clearance?

Aquadex FlexFlow System 2.0 received FDA 510(k) clearance on 2020-02-24, under 510(k) number K192756.

Who is the listed applicant for Aquadex FlexFlow System 2.0?

The FDA 510(k) record lists Chf Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquadex FlexFlow System 2.0?

The FDA product code for Aquadex FlexFlow System 2.0 is KDI.

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Fonte oficial

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