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FDA 510(k)

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)

K 號:K243030 · 2024-10-25

決定日期2024-10-25
產品代碼OHT
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is the device name listed in this FDA 510(k) record. The listed applicant is Ulike Co., Ltd.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K243030. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Ulike Co., Ltd.. The 510(k) number is K243030.

When did Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) receive FDA 510(k) clearance?

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) received FDA 510(k) clearance on 2024-10-25, under 510(k) number K243030.

Who is the listed applicant for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?

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

What is the FDA product code for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?

The FDA product code for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is OHT.

相關臨床試驗

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。

其他以 Ulike Co., Ltd. 為申請人之記錄

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。

相關器械(代碼:OHT)

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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