FDA 510(k)

用于ENFit注射器的防篡改帽

K号: K170672 · 2017-10-06

申请人International Medical Industries, Inc.

决定日期2017-10-06

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

Tamper Evident Cap For use with ENFit Syringes is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K170672. 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 Tamper Evident Cap For use with ENFit Syringes?

Tamper Evident Cap For use with ENFit Syringes is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K170672.

When did Tamper Evident Cap For use with ENFit Syringes receive FDA 510(k) clearance?

Tamper Evident Cap For use with ENFit Syringes received FDA 510(k) clearance on 2017-10-06, under 510(k) number K170672.

Who is the listed applicant for Tamper Evident Cap For use with ENFit Syringes?

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

What is the FDA product code for Tamper Evident Cap For use with ENFit Syringes?

The FDA product code for Tamper Evident Cap For use with ENFit Syringes is PNR.

列明International Medical Industries, 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。

K231095防篡改帽 K201031NRFit®帽，男性和女性神经轴帽 K193192防篡改帽 K190305附加帽 K182545带雄性Luer锁的防篡改帽 K173577Guarded Luer Connector

查看所有 7 个设备 →

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。