FDA 510(k)

Dental sensors NanoPix1, NanoPix2

Número K: K220422 · 2022-03-11

RequerenteIray Technology Taicang , Ltd.

Data da decisão2022-03-11

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental sensors NanoPix1, NanoPix2 is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K220422. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental sensors NanoPix1, NanoPix2?

Dental sensors NanoPix1, NanoPix2 is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K220422.

When did Dental sensors NanoPix1, NanoPix2 receive FDA 510(k) clearance?

Dental sensors NanoPix1, NanoPix2 received FDA 510(k) clearance on 2022-03-11, under 510(k) number K220422.

Who is the listed applicant for Dental sensors NanoPix1, NanoPix2?

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

What is the FDA product code for Dental sensors NanoPix1, NanoPix2?

The FDA product code for Dental sensors NanoPix1, NanoPix2 is MUH.

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Fonte oficial

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