SmartStart 空气/水及吸引阀
K号: K160403 · 2016-05-19
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决定日期2016-05-19
产品代码ODC
咨询委员会GU
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决定实质等同
器械摘要
SmartStart Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K160403. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmartStart Air/Water and Suction Valves?
SmartStart Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Endochoice, Inc.. The 510(k) number is K160403.
When did SmartStart Air/Water and Suction Valves receive FDA 510(k) clearance?
SmartStart Air/Water and Suction Valves received FDA 510(k) clearance on 2016-05-19, under 510(k) number K160403.
Who is the listed applicant for SmartStart Air/Water and Suction Valves?
The FDA 510(k) record lists Endochoice, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartStart Air/Water and Suction Valves?
The FDA product code for SmartStart Air/Water and Suction Valves is ODC.
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Endochoice, 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：ODC）
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。
K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca 空气/水及吸阀Boston ScientificK250949吸水阀（MAJ-1443）；空气/水阀（MAJ-1444）Olympus Medical Systems CorporationK250732一次性内窥镜阀门套装Yangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation
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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