FDA 510(k)

富士通內視鏡CO2調節器 GW-100

K 號：K180711 · 2018-05-25

決定日期2018-05-25

產品代碼FCX

諮詢委員會GU

決定相當於

器材摘要

FUJIFILM Endoscopic CO2 Regulator GW-100 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K180711. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FUJIFILM Endoscopic CO2 Regulator GW-100?

FUJIFILM Endoscopic CO2 Regulator GW-100 is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Fujifilm Corporation. The 510(k) number is K180711.

When did FUJIFILM Endoscopic CO2 Regulator GW-100 receive FDA 510(k) clearance?

FUJIFILM Endoscopic CO2 Regulator GW-100 received FDA 510(k) clearance on 2018-05-25, under 510(k) number K180711.

Who is the listed applicant for FUJIFILM Endoscopic CO2 Regulator GW-100?

FDA 510(k) 記錄中將富士通公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for FUJIFILM Endoscopic CO2 Regulator GW-100?

The FDA product code for FUJIFILM Endoscopic CO2 Regulator GW-100 is FCX.

其他以 Fujifilm Corporation 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。

K261229SCENARIA 觀察階段 6.0 K261283APERTO Lucent MRI 系統 K253836FCT iStream 階段 2 K261170BA-004CC K260567EW10-EC02內視鏡輔助程序 K261880富士通電子處理器EP-8000；氣球控制器PB-30；內視鏡輔助程序EW10-VM01

查看所有 70 項裝置 →

相關器械（代碼：FCX）

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。

K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.K230474EVA5 充氣器Palliare , Ltd.K202922結束 200 絶締內視鏡管路組Palliare , Ltd.K201096CO2雙合式Karl Storz Endoscopy America, Inc.K190985BAROnova 空氣注入系統，BAROnova 道具套件Baronova, Inc.

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。