FDA 510(k)

迪阿科爾

K 號：K253926 · 2026-04-10

決定日期2026-04-10

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Diacore is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K253926. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diacore?

Diacore is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K253926.

When did Diacore receive FDA 510(k) clearance?

Diacore received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253926.

Who is the listed applicant for Diacore?

The FDA 510(k) record lists ShenB Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diacore?

The FDA product code for Diacore is NGX.

其他以 ShenB Co., Ltd. 為申請人之記錄

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相關器械（代碼：NGX）

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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