氣管內管
K 號：K190274 · 2019-07-30
廣告
器材摘要
Endotracheal Tube is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K190274. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Endotracheal Tube?
Endotracheal Tube is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. The 510(k) number is K190274.
When did Endotracheal Tube receive FDA 510(k) clearance?
Endotracheal Tube received FDA 510(k) clearance on 2019-07-30, under 510(k) number K190274.
Who is the listed applicant for Endotracheal Tube?
The FDA 510(k) record lists Tianjin Medis Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endotracheal Tube?
The FDA product code for Endotracheal Tube is BTR.
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 Tianjin Medis Medical Device Co., Ltd. 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：BTR）
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。
K251794Tenax® 適應激光內氣管管Bryan Medical, Inc.K253437斯匹羅-維斯塔Spiro RoboticsK250173Shiley™ 口腔RAE 氣管管無氣囊，墨菲眼（113-XX）Shiley™ 鼻腔RAE 氣管管無氣囊，墨菲眼（114-XX）Shiley™ 口腔RAE 氣管管有氣囊，墨菲眼（115-XX）Shiley™ 口腔RAE 氣管管配TaperGuard™ 氣囊，墨菲眼（115-XXOR）Shiley™ 鼻腔RAE 氣管管配TaperGuard™ 氣囊，墨菲眼（119-XXNR）Covidien, LLCK243785Shiley™ 口腔/鼻腔氣管配TaperGuard™ 膨脹環加強，Murphy 眼 Shiley™ 氣管管 TaperGuard™ 膨脹環加強並帶針 Shiley™ 低曲線口腔/鼻腔氣管配氣管加強 Shiley™ 低曲線口腔/鼻腔氣管配氣管加強，Murphy 眼 Shiley™ 口腔/鼻腔氣管無氣管加強Covidien, LLCK243579AeroJet 通氣導尿管Pipeline Medical Products, LLCK251499Frova 通氣導管引入器 (C-CAE-14.0-70-FII)；Frova 通氣導管引入器 (C-CAE-14.0-70-FI)；Frova 通氣導管引入器 (C-CAE-14.0-70-FIC)；Frova 通氣導管引入器 (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps
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