NubeX
K 號:K211480 · 2021-07-08
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器材摘要
NubeX is the device name listed in this FDA 510(k) record. The listed applicant is Techheim Co., Ltd.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K211480. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NubeX?
NubeX is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Techheim Co., Ltd.. The 510(k) number is K211480.
When did NubeX receive FDA 510(k) clearance?
NubeX received FDA 510(k) clearance on 2021-07-08, under 510(k) number K211480.
Who is the listed applicant for NubeX?
The FDA 510(k) record lists Techheim Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NubeX?
The FDA product code for NubeX is LLZ.
相關臨床試驗
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相關器械(代碼:LLZ)
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。
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