Mico One 正畸螺釘
K 號：K202163 · 2022-10-07
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器材摘要
Mico One Orthodontic Screw is the device name listed in this FDA 510(k) record. The listed applicant is Ze Fang Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K202163. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Mico One Orthodontic Screw?
Mico One Orthodontic Screw is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Ze Fang Technology Co., Ltd.. The 510(k) number is K202163.
When did Mico One Orthodontic Screw receive FDA 510(k) clearance?
Mico One Orthodontic Screw received FDA 510(k) clearance on 2022-10-07, under 510(k) number K202163.
Who is the listed applicant for Mico One Orthodontic Screw?
The FDA 510(k) record lists Ze Fang Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mico One Orthodontic Screw?
The FDA product code for Mico One Orthodontic Screw is OAT.
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。
相關器械（代碼：OAT）
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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