ZeroClear™袋接入（423100）
K号: K243976 · 2025-01-22
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决定日期2025-01-22
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
ZeroClear™ Bag Access (423100) is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-01-22 under 510(k) number K243976. 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 ZeroClear™ Bag Access (423100)?
ZeroClear™ Bag Access (423100) is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K243976.
When did ZeroClear™ Bag Access (423100) receive FDA 510(k) clearance?
ZeroClear™ Bag Access (423100) received FDA 510(k) clearance on 2025-01-22, under 510(k) number K243976.
Who is the listed applicant for ZeroClear™ Bag Access (423100)?
The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZeroClear™ Bag Access (423100)?
The FDA product code for ZeroClear™ Bag Access (423100) 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Epic Medical Pte. , 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.K240517ProSeal™ 带排气孔的通用安瓿瓶适配器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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