FDA 510(k)

ETView VivaSight-SL (TVT) 系統

K 號：K152438 · 2016-02-25

決定日期2016-02-25

產品代碼BTR

諮詢委員會AN

決定相當於

器材摘要

ETView VivaSight-SL (TVT) system is the device name listed in this FDA 510(k) record. The listed applicant is Etview , Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152438. 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 ETView VivaSight-SL (TVT) system?

ETView VivaSight-SL (TVT) system is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Etview , Ltd.. The 510(k) number is K152438.

When did ETView VivaSight-SL (TVT) system receive FDA 510(k) clearance?

ETView VivaSight-SL (TVT) system received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152438.

Who is the listed applicant for ETView VivaSight-SL (TVT) system?

The FDA 510(k) record lists Etview , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETView VivaSight-SL (TVT) system?

The FDA product code for ETView VivaSight-SL (TVT) system is BTR.

其他以 Etview , 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。

K181880VivaSight-SL (TVT) 系統 K181886VivaSight-DL 系統

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。