清晰影像正畸器
K 號：K183643 · 2019-01-03
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器材摘要
Clear Image Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Appliance Works, Inc.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K183643. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Clear Image Aligners?
Clear Image Aligners is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Specialty Appliance Works, Inc.. The 510(k) number is K183643.
When did Clear Image Aligners receive FDA 510(k) clearance?
Clear Image Aligners received FDA 510(k) clearance on 2019-01-03, under 510(k) number K183643.
Who is the listed applicant for Clear Image Aligners?
The FDA 510(k) record lists Specialty Appliance Works, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clear Image Aligners?
The FDA product code for Clear Image Aligners is NXC.
相關臨床試驗
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相關器械（代碼：NXC）
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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