eZSURE™ 空液容器
K号: K252094 · 2025-08-01
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决定日期2025-08-01
产品代码KPE
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
eZSURE™ Empty Fluid Container 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 2025-08-01 under 510(k) number K252094. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the eZSURE™ Empty Fluid Container?
eZSURE™ Empty Fluid Container is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K252094.
When did eZSURE™ Empty Fluid Container receive FDA 510(k) clearance?
eZSURE™ Empty Fluid Container received FDA 510(k) clearance on 2025-08-01, under 510(k) number K252094.
Who is the listed applicant for eZSURE™ Empty Fluid Container?
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 eZSURE™ Empty Fluid Container?
The FDA product code for eZSURE™ Empty Fluid Container is KPE.
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：KPE）
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。
K252079一次性肠外营养输液袋Beijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ 包Icu Medical, Inc.K251139KabiHelp® Uno；KabiHelp® Advance plusFresenius Kabi AGK250459DMRX 100ml空容器溶液；DMRX 250ml空容器溶液；DMRX 500ml空容器溶液；DMRX 1000ml空容器溶液Technoflex Sas.K241442eZSURE™ 带ProSeal™ 注射位的空液体容器Epic Medical Pte. , Ltd.K223674eZSURE™ 空液容器（型号426030、426040、426110）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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