FDA 510(k)

RFA-1717DIG, RFA-1717DIC

K 號：K212051 · 2021-08-25

決定日期2021-08-25

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：MQB）

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官方來源

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