FDA 510(k)

Asahi ViE-U Series Dialyzer

Número K: K162248 · 2017-05-03

Data da decisão2017-05-03

Código do produtoKDI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Asahi ViE-U Series Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K162248. 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 Asahi ViE-U Series Dialyzer?

Asahi ViE-U Series Dialyzer is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Asahi Kasei Medical Co., Ltd.. The 510(k) number is K162248.

When did Asahi ViE-U Series Dialyzer receive FDA 510(k) clearance?

Asahi ViE-U Series Dialyzer received FDA 510(k) clearance on 2017-05-03, under 510(k) number K162248.

Who is the listed applicant for Asahi ViE-U Series Dialyzer?

The FDA 510(k) record lists Asahi Kasei Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Asahi ViE-U Series Dialyzer?

The FDA product code for Asahi ViE-U Series Dialyzer is KDI.

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