藍天生物對齊器
K 號：K180107 · 2018-02-09
廣告
器材摘要
Blue Sky Bio Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K180107. 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 Blue Sky Bio Aligner?
Blue Sky Bio Aligner is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K180107.
When did Blue Sky Bio Aligner receive FDA 510(k) clearance?
Blue Sky Bio Aligner received FDA 510(k) clearance on 2018-02-09, under 510(k) number K180107.
Who is the listed applicant for Blue Sky Bio Aligner?
The FDA 510(k) record lists Blue Sky Bio, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Blue Sky Bio Aligner?
The FDA product code for Blue Sky Bio 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。
其他以 Blue Sky Bio, LLC 為申請人之記錄
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