FDA 510(k)

Labat series Diagnostic Ultrasound System

Número K: K210154 · 2021-07-30

RequerenteShenzhen Wisonic Medical Technology Co. , Ltd.

Data da decisão2021-07-30

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Labat series Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K210154. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Labat series Diagnostic Ultrasound System?

Labat series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K210154.

When did Labat series Diagnostic Ultrasound System receive FDA 510(k) clearance?

Labat series Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-07-30, under 510(k) number K210154.

Who is the listed applicant for Labat series Diagnostic Ultrasound System?

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

What is the FDA product code for Labat series Diagnostic Ultrasound System?

The FDA product code for Labat series Diagnostic Ultrasound System is IYN.

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Outros registros que listam Shenzhen Wisonic Medical Technology Co. , Ltd. como candidato(a)

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Fonte oficial

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