FDA 510(k)

AquaShield 系統 CO2, AquaShield 系統 CO2-PENTAX, AquaShield 系統 CO2-FUJIFILM

K 號：K191559 · 2019-08-01

決定日期2019-08-01

產品代碼FEQ

諮詢委員會GU

決定相當於

器材摘要

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K191559. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM?

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K191559.

When did AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM receive FDA 510(k) clearance?

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191559.

Who is the listed applicant for AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM?

The FDA product code for AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is FEQ.

其他以 United States Endoscopy Group, 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。

K192265gi-4000 電外科電流發生器 K200745Lariat, 熱/冷圈 K192059生物保護空氣/水及吸引閥 K182909羅思網絡回收器產品線 K182258AquaShield 系統 CO2 ; AquaShield 系統 CO2 - PENTAX ; AquaShield 系統 CO2 - Fujifilm K173650AquaShield System CO2-富士通

查看所有 10 項裝置 →

相關器械（代碼：FEQ）

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。

K220395EndoGator內視鏡灌洗管STERIS Corporation K182258AquaShield 系統 CO2 ; AquaShield 系統 CO2 - PENTAX ; AquaShield 系統 CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield System CO2-富士通United States Endoscopy Group, Inc.K163424AquaShield 系統 - PENTAX, AquaShield 系統 CO2 - PENTAX, AquaShield 系統 CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe的CO2管/蓋組Erbe USA, Inc.K161482EndoChoice 水壺蓋灌流系統Endochoice, 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。