Pure Vu
K号: K160015 · 2016-09-22
广告
决定日期2016-09-22
产品代码FDF
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
Pure Vu is the device name listed in this FDA 510(k) record. The listed applicant is Motus GI Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K160015. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pure Vu?
Pure Vu is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Motus GI Medical Technologies , Ltd.. The 510(k) number is K160015.
When did Pure Vu receive FDA 510(k) clearance?
Pure Vu received FDA 510(k) clearance on 2016-09-22, under 510(k) number K160015.
Who is the listed applicant for Pure Vu?
The FDA 510(k) record lists Motus GI Medical Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pure Vu?
The FDA product code for Pure Vu is FDF.
列明Motus GI Medical Technologies , Ltd.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:FDF)
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。
K260503特里顿1系统Neptune Medical, Inc.K261015独立视界结肠镜系统Gi View, Ltd.K261587充气保留装置(IRD)(11173-325-101)BPEndo, LLCK260423一次性内镜远端附件Yangzhou Fartley Medical Instrument Technology Co., Ltd.K252457一次性远端端头胶带罩Shanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA(ER-R-002);ROBOPERA(ER-R-003)Endorobotics Co., Ltd.
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。
广告