FDA 510(k)

Zeroveno

Número K: K192337 · 2020-06-22

Data da decisão2020-06-22

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Zeroveno is the device name listed in this FDA 510(k) record. The listed applicant is Dimedi Co., Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K192337. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Zeroveno?

Zeroveno is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Dimedi Co., Ltd.. The 510(k) number is K192337.

When did Zeroveno receive FDA 510(k) clearance?

Zeroveno received FDA 510(k) clearance on 2020-06-22, under 510(k) number K192337.

Who is the listed applicant for Zeroveno?

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

What is the FDA product code for Zeroveno?

The FDA product code for Zeroveno is JOW.

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