FDA 510(k)

Dexus Prosthetics System (Model: MSL1, MSR1)

Número K: K220002 · 2022-09-09

RequerenteZhejiang Qiangnao Technology Co.,Ltd

Data da decisão2022-09-09

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dexus Prosthetics System (Model: MSL1, MSR1) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Qiangnao Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-09-09 under 510(k) number K220002. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dexus Prosthetics System (Model: MSL1, MSR1)?

Dexus Prosthetics System (Model: MSL1, MSR1) is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Zhejiang Qiangnao Technology Co.,Ltd. The 510(k) number is K220002.

When did Dexus Prosthetics System (Model: MSL1, MSR1) receive FDA 510(k) clearance?

Dexus Prosthetics System (Model: MSL1, MSR1) received FDA 510(k) clearance on 2022-09-09, under 510(k) number K220002.

Who is the listed applicant for Dexus Prosthetics System (Model: MSL1, MSR1)?

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

What is the FDA product code for Dexus Prosthetics System (Model: MSL1, MSR1)?

The FDA product code for Dexus Prosthetics System (Model: MSL1, MSR1) is GXY.

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Fonte oficial

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