FDA 510(k)

EKOS超聲波EVD設備，EVD控制單元

K 號：K172035 · 2018-03-24

決定日期2018-03-24

產品代碼JXG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

EKOS ultrasound EVD Device, EVD Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Btg International, Inc.. It received FDA 510(k) clearance on 2018-03-24 under 510(k) number K172035. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EKOS ultrasound EVD Device, EVD Control Unit?

EKOS ultrasound EVD Device, EVD Control Unit is a medical device that received FDA 510(k) clearance on 2018-03-24. The listed applicant is Btg International, Inc.. The 510(k) number is K172035.

When did EKOS ultrasound EVD Device, EVD Control Unit receive FDA 510(k) clearance?

EKOS ultrasound EVD Device, EVD Control Unit received FDA 510(k) clearance on 2018-03-24, under 510(k) number K172035.

Who is the listed applicant for EKOS ultrasound EVD Device, EVD Control Unit?

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

What is the FDA product code for EKOS ultrasound EVD Device, EVD Control Unit?

The FDA product code for EKOS ultrasound EVD Device, EVD Control Unit is JXG.

其他以 Btg International, 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。

K191119EkoSonic內血管設備 K183361EkoSonic內血管設備搭配控制單元4.0 K182324EkoSonic內血管系統 K162771EkoSonic內血管系統配控制單元4.0

相關器械（代碼：JXG）

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。

K261004Codman® 遠端腹膜針管，铍白開口型（82-1682）；Codman® HOLTER® 腹膜針管（SALMON設計）（82-1684）Integra Lifesciences Production Corporation K251598智滴Brainspace, Inc.K250636Sophy Mini 單壓力閥 (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531科德曼Libertís分流針管搭配Bactiseal及Endexo技術Integra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD 腔管，配備 Bactiseal® 及 Endexo® 技術，並具有 Luer 接頭（821761）；Codman Libertís™ 1.9 mm EVD 腔管，配備 Bactiseal® 及 Endexo® 技術，並具有 Luer 接頭（821762）Integra Lifesciences Production Corporation

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。