Ez3D-i / E3
K 號：K231757 · 2023-07-14
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器材摘要
Ez3D-i /E3 is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K231757. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ez3D-i /E3?
Ez3D-i /E3 is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K231757.
When did Ez3D-i /E3 receive FDA 510(k) clearance?
Ez3D-i /E3 received FDA 510(k) clearance on 2023-07-14, under 510(k) number K231757.
Who is the listed applicant for Ez3D-i /E3?
The FDA 510(k) record lists Ewoosoft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ez3D-i /E3?
The FDA product code for Ez3D-i /E3 is QIH.
其他以 Ewoosoft Co., Ltd. 為申請人之記錄
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相關器械（代碼：QIH）
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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