FDA 510(k)

ENFit 口服/肠内注射器

K号: K190502 · 2019-08-06

决定日期2019-08-06

产品代码PNR

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决定实质等同

器械摘要

ENFit Oral / Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K190502. 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 ENFit Oral / Enteral Syringe?

ENFit Oral / Enteral Syringe is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K190502.

When did ENFit Oral / Enteral Syringe receive FDA 510(k) clearance?

ENFit Oral / Enteral Syringe received FDA 510(k) clearance on 2019-08-06, under 510(k) number K190502.

Who is the listed applicant for ENFit Oral / Enteral Syringe?

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

What is the FDA product code for ENFit Oral / Enteral Syringe?

The FDA product code for ENFit Oral / Enteral Syringe is PNR.

列明Jiangsu Caina Medical 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。

K232781安全滑动式血液采集套装 K233190ENFit 连接器 K230635笔式针头 K220184Pump Alignment Syringe K211593肠内泵注射器 K210217无针连接器

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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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