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FDA 510(k)

Any-Core

K 號:K252465 · 2025-12-05

決定日期2025-12-05
產品代碼EBF
諮詢委員會DE
決定相當於

器材摘要

Any-Core is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K252465. 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 Any-Core?

Any-Core is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K252465.

When did Any-Core receive FDA 510(k) clearance?

Any-Core received FDA 510(k) clearance on 2025-12-05, under 510(k) number K252465.

Who is the listed applicant for Any-Core?

FDA 510(k) 紀錄將 Mediclus Co., Ltd. 列為申請人。這本身並不確立醫療器材製造商。

What is the FDA product code for Any-Core?

The FDA product code for Any-Core is EBF.

其他以 Mediclus Co., Ltd. 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。

官方來源

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