FDA 510(k)

ENFit 可重复使用肠内注射器

K号: K203613 · 2021-08-27

申请人Shantou Wealy Medical Instrument Co.,Ltd

决定日期2021-08-27

产品代码PNR

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决定实质等同

器械摘要

ENFit Reusable Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K203613. 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 Reusable Enteral Syringe?

ENFit Reusable Enteral Syringe is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K203613.

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

ENFit Reusable Enteral Syringe received FDA 510(k) clearance on 2021-08-27, under 510(k) number K203613.

Who is the listed applicant for ENFit Reusable Enteral Syringe?

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

What is the FDA product code for ENFit Reusable Enteral Syringe?

The FDA product code for ENFit Reusable Enteral Syringe is PNR.

列明Shantou Wealy Medical Instrument 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。

K222452一次性自动回缩安全注射器（带可拆卸针头）K210216一次性自动回缩胰岛素安全注射器 K203410ENFit 一次性肠内注射器

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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