FDA 510(k)

带ENfit连接器的肠内营养注射器（型号：10毫升；60毫升控制环）

K号: K200557 · 2020-09-28

申请人Jiangsu Shenli Medical Production Co., Ltd.

决定日期2020-09-28

产品代码PNR

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决定实质等同

器械摘要

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K200557. 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 connector (Model: 10 ml; 60 ml control ring)?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is a medical device that received FDA 510(k) clearance on 2020-09-28. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K200557.

When did Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) receive FDA 510(k) clearance?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) received FDA 510(k) clearance on 2020-09-28, under 510(k) number K200557.

Who is the listed applicant for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

The FDA 510(k) record lists Jiangsu Shenli Medical Production 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 connector (Model: 10 ml; 60 ml control ring)?

The FDA product code for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is PNR.

列明Jiangsu Shenli Medical Production 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。

K180259无菌一次性使用皮下注射针 K163093安全血液采集套装

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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