FDA 510(k)

C&B NFH 混合式醫療設備

K 號：K232559 · 2024-09-11

決定日期2024-09-11

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

C&B NFH Hybrid is the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2024-09-11 under 510(k) number K232559. 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 C&B NFH Hybrid?

C&B NFH Hybrid is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K232559.

When did C&B NFH Hybrid receive FDA 510(k) clearance?

C&B NFH Hybrid received FDA 510(k) clearance on 2024-09-11, under 510(k) number K232559.

Who is the listed applicant for C&B NFH Hybrid?

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

What is the FDA product code for C&B NFH Hybrid?

The FDA product code for C&B NFH Hybrid is EBF.

其他以 Arum Dentistry 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。

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