FDA 510(k)

带Enfit连接器的肠内营养注射器

K号: K182649 · 2018-11-09

申请人Jiangsu Kangbao Medical Equipment Co., Ltd.

决定日期2018-11-09

产品代码PNR

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

Enteral Feeding Syringes with Enfit Connectors is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182649. 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 Enteral Feeding Syringes with Enfit Connectors?

Enteral Feeding Syringes with Enfit Connectors is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. The 510(k) number is K182649.

When did Enteral Feeding Syringes with Enfit Connectors receive FDA 510(k) clearance?

Enteral Feeding Syringes with Enfit Connectors received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182649.

Who is the listed applicant for Enteral Feeding Syringes with Enfit Connectors?

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

What is the FDA product code for Enteral Feeding Syringes with Enfit Connectors?

The FDA product code for Enteral Feeding Syringes with Enfit Connectors is PNR.

列明Jiangsu Kangbao Medical Equipment 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。

K232881翼型输液器，安全翼型输液器，血液采集套装，带夹血液采集套装，安全血液采集套装，带夹安全血液采集套装 K221247无菌一次性使用安全注射器，无菌一次性使用注射器，无菌一次性使用安全针，无菌一次性使用针 K211329无菌一次性使用安全针，无菌一次性使用注射器，无菌一次性使用注射器，无菌一次性使用安全针，无菌一次性使用针 K192681安全头皮静脉套件，头皮静脉套件，采血针（头皮静脉套件型），采血针（针夹型），安全采血针（头皮静脉套件型），安全采血针（针夹型）

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

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。