FDA 510(k)

GrandioSO 輕流

K 號：K200294 · 2020-03-27

決定日期2020-03-27

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

GrandioSO Light Flow is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K200294. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GrandioSO Light Flow?

GrandioSO Light Flow is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Voco GmbH. The 510(k) number is K200294.

When did GrandioSO Light Flow receive FDA 510(k) clearance?

GrandioSO Light Flow received FDA 510(k) clearance on 2020-03-27, under 510(k) number K200294.

Who is the listed applicant for GrandioSO Light Flow?

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

What is the FDA product code for GrandioSO Light Flow?

The FDA product code for GrandioSO Light Flow is EBF.

其他以 Voco GmbH 為申請人之記錄

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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相關器械（代碼：EBF）

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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