FDA 510(k)

TEVADAPTOR 封闭式药物复配和转移系统

K号: K170680 · 2017-05-16

决定日期2017-05-16

产品代码ONB

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

TEVADAPTOR Closed Drug Reconstitution and Transfer System is the device name listed in this FDA 510(k) record. The listed applicant is Teva Medical Ltd., Migada Plant. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K170680. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TEVADAPTOR Closed Drug Reconstitution and Transfer System?

TEVADAPTOR Closed Drug Reconstitution and Transfer System is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Teva Medical Ltd., Migada Plant. The 510(k) number is K170680.

When did TEVADAPTOR Closed Drug Reconstitution and Transfer System receive FDA 510(k) clearance?

TEVADAPTOR Closed Drug Reconstitution and Transfer System received FDA 510(k) clearance on 2017-05-16, under 510(k) number K170680.

Who is the listed applicant for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA 510(k) record lists Teva Medical Ltd., Migada Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System is ONB.

列明Teva Medical Ltd., Migada Plant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。

K180489TEVADAPTOR 封闭式药物复配和转移系统

相关器械（代码：ONB）

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。

K251722ProSeal™ 转移注射器 (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28天 20毫米安瓿适配器和13毫米转换器Simplivia Healthcare , Ltd.K250059BD PhaSeal® Optima 连接套件（C83-O）；BD PhaSeal® Optima 喷嘴套件（C180-O）Becton, Dickinson and Company K251411Chemfort 女性卢瑞锁适配器Simplivia Healthcare , Ltd.K251340ProSeal™带添加剂端口的袋刺（423370ST，423370）Epic Medical Pte. , Ltd.K243976ZeroClear™袋接入（423100）Epic Medical Pte. , Ltd.

官方来源

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