FDA 510(k)

GrandioSO x-tra

K 號：K181312 · 2018-08-22

決定日期2018-08-22

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

GrandioSO x-tra is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2018-08-22 under 510(k) number K181312. 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 x-tra?

GrandioSO x-tra is a medical device that received FDA 510(k) clearance on 2018-08-22. The listed applicant is Voco GmbH. The 510(k) number is K181312.

When did GrandioSO x-tra receive FDA 510(k) clearance?

GrandioSO x-tra received FDA 510(k) clearance on 2018-08-22, under 510(k) number K181312.

Who is the listed applicant for GrandioSO x-tra?

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 x-tra?

The FDA product code for GrandioSO x-tra is EBF.

其他以 Voco GmbH 為申請人之記錄

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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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