Erbe 的 CO2 管/盖套装
K号: K162152 · 2016-08-31
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决定日期2016-08-31
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
Erbe’s CO2 Tubing/Cap Sets is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K162152. 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 Erbe’s CO2 Tubing/Cap Sets?
Erbe’s CO2 Tubing/Cap Sets is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Erbe USA, Inc.. The 510(k) number is K162152.
When did Erbe’s CO2 Tubing/Cap Sets receive FDA 510(k) clearance?
Erbe’s CO2 Tubing/Cap Sets received FDA 510(k) clearance on 2016-08-31, under 510(k) number K162152.
Who is the listed applicant for Erbe’s CO2 Tubing/Cap Sets?
The FDA 510(k) record lists Erbe USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Erbe’s CO2 Tubing/Cap Sets?
The FDA product code for Erbe’s CO2 Tubing/Cap Sets 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。
列明Erbe USA, Inc.为申报人的其他记录
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。
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.K163424AquaShield 系统 - PENTAX, AquaShield 系统 CO2 - PENTAX, AquaShield 系统 CO2 - FUJINONUnited State Endoscopy Group, Inc.K161482EndoChoice 水瓶盖冲洗系统Endochoice, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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