FDA 510(k)

瑞輝olve

K 號：K220164 · 2022-06-02

決定日期2022-06-02

產品代碼QBS

諮詢委員會RA

決定相當於

器材摘要

Rayvolve is the device name listed in this FDA 510(k) record. The listed applicant is Azmed Sas. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K220164. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rayvolve?

Rayvolve is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Azmed Sas. The 510(k) number is K220164.

When did Rayvolve receive FDA 510(k) clearance?

Rayvolve received FDA 510(k) clearance on 2022-06-02, under 510(k) number K220164.

Who is the listed applicant for Rayvolve?

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

What is the FDA product code for Rayvolve?

The FDA product code for Rayvolve is QBS.

其他以 Azmed Sas 為申請人之記錄

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K240845瑞輝olve

相關器械（代碼：QBS）

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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官方來源

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