FDA 510(k)

RFA-1717DIG, RFA-1717DIC

Número K: K212051 · 2021-08-25

Data da decisão2021-08-25

Código do produtoMQB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

RFA-1717DIG, RFA-1717DIC is the device name listed in this FDA 510(k) record. The listed applicant is Astel, Inc.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K212051. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RFA-1717DIG, RFA-1717DIC?

RFA-1717DIG, RFA-1717DIC is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Astel, Inc.. The 510(k) number is K212051.

When did RFA-1717DIG, RFA-1717DIC receive FDA 510(k) clearance?

RFA-1717DIG, RFA-1717DIC received FDA 510(k) clearance on 2021-08-25, under 510(k) number K212051.

Who is the listed applicant for RFA-1717DIG, RFA-1717DIC?

The FDA 510(k) record lists Astel, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RFA-1717DIG, RFA-1717DIC?

The FDA product code for RFA-1717DIG, RFA-1717DIC is MQB.

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Fonte oficial

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