FDA 510(k)

Tenax 適應激光內氣管管

K 號：K213028 · 2021-10-21

決定日期2021-10-21

產品代碼BTR

諮詢委員會AN

決定相當於

器材摘要

Tenax Laser Resistant Endotracheal Tube is the device name listed in this FDA 510(k) record. The listed applicant is Bryan Medical, Inc.. It received FDA 510(k) clearance on 2021-10-21 under 510(k) number K213028. 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 Tenax Laser Resistant Endotracheal Tube?

Tenax Laser Resistant Endotracheal Tube is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Bryan Medical, Inc.. The 510(k) number is K213028.

When did Tenax Laser Resistant Endotracheal Tube receive FDA 510(k) clearance?

Tenax Laser Resistant Endotracheal Tube received FDA 510(k) clearance on 2021-10-21, under 510(k) number K213028.

Who is the listed applicant for Tenax Laser Resistant Endotracheal Tube?

FDA 510(k) 記錄將 Bryan Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Tenax Laser Resistant Endotracheal Tube?

The FDA product code for Tenax Laser Resistant Endotracheal Tube is BTR.

其他以 Bryan Medical, Inc. 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。

K251794Tenax® 適應激光內氣管管 K200761Tenax 適應激光內氣管管

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 Robotics K250173Shiley™ 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, LLC K243785Shiley™ 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, LLC K243579AeroJet 通氣導尿管Pipeline Medical Products, LLC K251499Frova 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。