FDA 510(k)

GrandioSO無限版

K 號：K251239 · 2025-05-21

決定日期2025-05-21

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

GrandioSO Unlimited is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K251239. 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 Unlimited?

GrandioSO Unlimited is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Voco GmbH. The 510(k) number is K251239.

When did GrandioSO Unlimited receive FDA 510(k) clearance?

GrandioSO Unlimited received FDA 510(k) clearance on 2025-05-21, under 510(k) number K251239.

Who is the listed applicant for GrandioSO Unlimited?

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 Unlimited?

The FDA product code for GrandioSO Unlimited 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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官方來源

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