FDA 510(k)

Medela 低剂量肠内注射器

K号: K161811 · 2017-02-15

决定日期2017-02-15

产品代码PNR

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决定实质等同

器械摘要

Medela Low Dose Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 2017-02-15 under 510(k) number K161811. 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 Medela Low Dose Enteral Syringe?

Medela Low Dose Enteral Syringe is a medical device that received FDA 510(k) clearance on 2017-02-15. The listed applicant is Medela, Inc.. The 510(k) number is K161811.

When did Medela Low Dose Enteral Syringe receive FDA 510(k) clearance?

Medela Low Dose Enteral Syringe received FDA 510(k) clearance on 2017-02-15, under 510(k) number K161811.

Who is the listed applicant for Medela Low Dose Enteral Syringe?

The FDA 510(k) record lists Medela, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medela Low Dose Enteral Syringe?

The FDA product code for Medela Low Dose Enteral Syringe is PNR.

列明Medela, Inc.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。

K161725Sonata 奶泵豪华版，Sonata 保修奶泵，双泵管路套装，零售，连接器备件套装，硅胶膜，零售，电源适配器，零售

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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