Equashield 闭式系统转移装置
K号: K221513 · 2023-02-17
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决定日期2023-02-17
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
Equashield Closed System Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is Equashield Medical , Ltd.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221513. 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 Equashield Closed System Transfer Device?
Equashield Closed System Transfer Device is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Equashield Medical , Ltd.. The 510(k) number is K221513.
When did Equashield Closed System Transfer Device receive FDA 510(k) clearance?
Equashield Closed System Transfer Device received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221513.
Who is the listed applicant for Equashield Closed System Transfer Device?
The FDA 510(k) record lists Equashield Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Equashield Closed System Transfer Device?
The FDA product code for Equashield Closed System Transfer Device is ONB.
相关临床试验
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。
列明Equashield Medical , 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。
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 CompanyK251411Chemfort 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
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。
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