歐倫道夫清潔正畸器
K 號：K210540 · 2021-05-19
廣告
器材摘要
Ohlendorf Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Ohlendorf Appliance Laboratory. It received FDA 510(k) clearance on 2021-05-19 under 510(k) number K210540. 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 Ohlendorf Clear Aligner?
Ohlendorf Clear Aligner is a medical device that received FDA 510(k) clearance on 2021-05-19. The listed applicant is Ohlendorf Appliance Laboratory. The 510(k) number is K210540.
When did Ohlendorf Clear Aligner receive FDA 510(k) clearance?
Ohlendorf Clear Aligner received FDA 510(k) clearance on 2021-05-19, under 510(k) number K210540.
Who is the listed applicant for Ohlendorf Clear Aligner?
The FDA 510(k) record lists Ohlendorf Appliance Laboratory as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ohlendorf Clear Aligner?
The FDA product code for Ohlendorf Clear Aligner is NXC.
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：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。
廣告