FDA 510(k)

Digital Ultrasonic Diagnostic Imaging System (Model: F6)

Número K: K231930 · 2024-03-22

RequerenteGuangdong Youkey Medical Co., Ltd.

Data da decisão2024-03-22

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Ultrasonic Diagnostic Imaging System (Model: F6) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Youkey Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K231930. 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 Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Guangdong Youkey Medical Co., Ltd.. The 510(k) number is K231930.

When did Digital Ultrasonic Diagnostic Imaging System (Model: F6) receive FDA 510(k) clearance?

Digital Ultrasonic Diagnostic Imaging System (Model: F6) received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231930.

Who is the listed applicant for Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

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

What is the FDA product code for Digital Ultrasonic Diagnostic Imaging System (Model: F6)?

The FDA product code for Digital Ultrasonic Diagnostic Imaging System (Model: F6) is IYN.

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