INT輪廓
K 號：K212274 · 2022-04-08
廣告
器材摘要
INT Contour is the device name listed in this FDA 510(k) record. The listed applicant is Carina Medical, LLC. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K212274. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the INT Contour?
INT Contour is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Carina Medical, LLC. The 510(k) number is K212274.
When did INT Contour receive FDA 510(k) clearance?
INT Contour received FDA 510(k) clearance on 2022-04-08, under 510(k) number K212274.
Who is the listed applicant for INT Contour?
The FDA 510(k) record lists Carina Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INT Contour?
The FDA product code for INT Contour is MUJ.
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 Carina Medical, 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：MUJ）
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