FDA 510(k)

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)

Número K: K211321 · 2022-10-13

RequerenteGuangzhou Sonostar Technologies Co., Ltd.

Data da decisão2022-10-13

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Sonostar Technologies Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K211321. 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 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)?

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Guangzhou Sonostar Technologies Co., Ltd.. The 510(k) number is K211321.

When did Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) receive FDA 510(k) clearance?

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) received FDA 510(k) clearance on 2022-10-13, under 510(k) number K211321.

Who is the listed applicant for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)?

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

What is the FDA product code for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)?

The FDA product code for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is IYN.

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Outros registros que listam Guangzhou Sonostar Technologies Co., Ltd. como candidato(a)

K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)K171926C5 Diagnostic Ultrasound System

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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