FDA 510(k)

U&U 肠内注射器

K号: K160855 · 2016-11-22

决定日期2016-11-22

产品代码PNR

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决定实质等同

器械摘要

U&U Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160855. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the U&U Enteral Syringe?

U&U Enteral Syringe is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K160855.

When did U&U Enteral Syringe receive FDA 510(k) clearance?

U&U Enteral Syringe received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160855.

Who is the listed applicant for U&U Enteral Syringe?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U Enteral Syringe?

The FDA product code for U&U Enteral Syringe is PNR.

列明U&U Medical Technology Co, 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。

K181508U&U 血液采集套装 K171823U&U 指示胶带和条带 K152808U&U胰岛素注射器（带/不带安全可缩回装置）

相关器械（代码：PNR）

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。

K252483肠内注射器（20ml，60ml）Chirana T.Injecta,A.S.K253268Profoject 鼻饲/口饲注射器；Profoject 可重复使用鼻饲/口饲注射器（型号A，型号B）；Profoject ENFit 连接器；Profoject 鼻饲注射器盖CMT Health PTE., Ltd.K251585Profoject™ 鼻饲注射器CMT Health PTE., Ltd.K243652Monoject® Enteral Syringe with ENFit Connector (401SE); Monoject® Enteral Syringe with ENFit Connector (403SE); Monoject® Enteral Syringe with ENFit Connector (406SE); Monoject® Enteral Syringe with ENFit Connector (412SE); Monoject® Enteral Syringe with ENFit Connector (435SE); Monoject® Enteral Syringe with ENFit Connector (460SE)Cardinalhealth K231300Nutricair Enteral Syringe with ENFitCair Lgl K222772带ENFit连接器的口腔/肠内注射器Anhui Tiankang Medical Technology Co., Ltd.

官方来源

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