FDA 510(k)

光耀V4

K 號：K171885 · 2017-07-25

申請人Gmv Soluciones Globales Internet S.A.U.

決定日期2017-07-25

產品代碼MUJ

諮詢委員會RA

決定相當於

器材摘要

Radiance V4 is the device name listed in this FDA 510(k) record. The listed applicant is Gmv Soluciones Globales Internet S.A.U.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K171885. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Radiance V4?

Radiance V4 is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Gmv Soluciones Globales Internet S.A.U.. The 510(k) number is K171885.

When did Radiance V4 receive FDA 510(k) clearance?

Radiance V4 received FDA 510(k) clearance on 2017-07-25, under 510(k) number K171885.

Who is the listed applicant for Radiance V4?

The FDA 510(k) record lists Gmv Soluciones Globales Internet S.A.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radiance V4?

The FDA product code for Radiance V4 is MUJ.

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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