N1
K 號：K232012 · 2023-11-28
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器材摘要
N1 is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K232012. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the N1?
N1 is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K232012.
When did N1 receive FDA 510(k) clearance?
N1 received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232012.
Who is the listed applicant for N1?
The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for N1?
The FDA product code for N1 is EHD.
其他以 Osstem Implant Co., Ltd. 為申請人之記錄
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相關器械（代碼：EHD）
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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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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