FDA 510(k)

Frozen N

Número K: K193665 · 2020-05-28

Data da decisão2020-05-28

Código do produtoGEH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Frozen N is the device name listed in this FDA 510(k) record. The listed applicant is Yozma Bmtech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-28 under 510(k) number K193665. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Frozen N?

Frozen N is a medical device that received FDA 510(k) clearance on 2020-05-28. The listed applicant is Yozma Bmtech Co., Ltd.. The 510(k) number is K193665.

When did Frozen N receive FDA 510(k) clearance?

Frozen N received FDA 510(k) clearance on 2020-05-28, under 510(k) number K193665.

Who is the listed applicant for Frozen N?

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

What is the FDA product code for Frozen N?

The FDA product code for Frozen N is GEH.

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