FDA 510(k)

wettrust D2care

Número K: K170797 · 2017-12-06

Data da decisão2017-12-06

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

wettrust D2care is the device name listed in this FDA 510(k) record. The listed applicant is Wettrust Korea Co., Ltd.. It received FDA 510(k) clearance on 2017-12-06 under 510(k) number K170797. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the wettrust D2care?

wettrust D2care is a medical device that received FDA 510(k) clearance on 2017-12-06. The listed applicant is Wettrust Korea Co., Ltd.. The 510(k) number is K170797.

When did wettrust D2care receive FDA 510(k) clearance?

wettrust D2care received FDA 510(k) clearance on 2017-12-06, under 510(k) number K170797.

Who is the listed applicant for wettrust D2care?

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

What is the FDA product code for wettrust D2care?

The FDA product code for wettrust D2care is NUC.

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