正畸面罩
K 號：K202855 · 2021-06-21
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器材摘要
Orthodontic Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Ita.O Italian Orthodontic System S.R.L.. It received FDA 510(k) clearance on 2021-06-21 under 510(k) number K202855. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Orthodontic Facemask?
Orthodontic Facemask is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Ita.O Italian Orthodontic System S.R.L.. The 510(k) number is K202855.
When did Orthodontic Facemask receive FDA 510(k) clearance?
Orthodontic Facemask received FDA 510(k) clearance on 2021-06-21, under 510(k) number K202855.
Who is the listed applicant for Orthodontic Facemask?
The FDA 510(k) record lists Ita.O Italian Orthodontic System S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orthodontic Facemask?
The FDA product code for Orthodontic Facemask is DZB.
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：DZB）
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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