FDA 510(k)

Pocket Ultrasound System

N.º K: K211746 · 2022-02-18

SolicitanteGuangdong Youkey Medical Co., Ltd.

Fecha de decisión2022-02-18

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pocket Ultrasound System 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 2022-02-18 under 510(k) number K211746. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pocket Ultrasound System?

Pocket Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Guangdong Youkey Medical Co., Ltd.. The 510(k) number is K211746.

When did Pocket Ultrasound System receive FDA 510(k) clearance?

Pocket Ultrasound System received FDA 510(k) clearance on 2022-02-18, under 510(k) number K211746.

Who is the listed applicant for Pocket Ultrasound System?

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 Pocket Ultrasound System?

The FDA product code for Pocket Ultrasound System is IYN.

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Fuente oficial

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