美瓷質牙弓絲架
K 號：K190608 · 2019-11-04
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器材摘要
Mei Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Orthosun Co., Ltd.. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K190608. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Mei Ceramic Bracket?
Mei Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Orthosun Co., Ltd.. The 510(k) number is K190608.
When did Mei Ceramic Bracket receive FDA 510(k) clearance?
Mei Ceramic Bracket received FDA 510(k) clearance on 2019-11-04, under 510(k) number K190608.
Who is the listed applicant for Mei Ceramic Bracket?
The FDA 510(k) record lists Orthosun Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mei Ceramic Bracket?
The FDA product code for Mei Ceramic Bracket is NJM.
相關臨床試驗
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相關器械（代碼：NJM）
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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