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FDA 510(k)

AquaShield 系统 - PENTAX, AquaShield 系统 CO2 - PENTAX, AquaShield 系统 CO2 - FUJINON

K号: K163424 · 2017-01-04

申请人United State Endoscopy Group, Inc.
决定日期2017-01-04
产品代码FEQ
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is the device name listed in this FDA 510(k) record. The listed applicant is United State Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K163424. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is United State Endoscopy Group, Inc.. The 510(k) number is K163424.

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

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON received FDA 510(k) clearance on 2017-01-04, under 510(k) number K163424.

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

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

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

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

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：FEQ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220395EndoGator 内窥镜冲洗管STERIS CorporationK191559AquaShield 系统 CO2, AquaShield 系统 CO2-PENTAX, AquaShield 系统 CO2-FUJIFILMUnited States Endoscopy Group, Inc.K182258AquaShield 系统 CO2 ; AquaShield 系统 CO2 - PENTAX ; AquaShield 系统 CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield 系统 CO2- FujifilmUnited States Endoscopy Group, Inc.K162152Erbe 的 CO2 管/盖套装Erbe USA, Inc.K161482EndoChoice 水瓶盖冲洗系统Endochoice, Inc.

官方来源

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