Clearform 調整器
K 號：K191838 · 2020-03-20
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器材摘要
Clearform Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Motor City Lab Works. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K191838. 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 Clearform Aligners?
Clearform Aligners is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Motor City Lab Works. The 510(k) number is K191838.
When did Clearform Aligners receive FDA 510(k) clearance?
Clearform Aligners received FDA 510(k) clearance on 2020-03-20, under 510(k) number K191838.
Who is the listed applicant for Clearform Aligners?
The FDA 510(k) record lists Motor City Lab Works as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clearform Aligners?
The FDA product code for Clearform 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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