空EVA袋
K号: K210749 · 2021-08-19
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决定日期2021-08-19
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
Empty EVA Bag is the device name listed in this FDA 510(k) record. The listed applicant is Haemotronic S.P.A.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K210749. 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 Empty EVA Bag?
Empty EVA Bag is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Haemotronic S.P.A.. The 510(k) number is K210749.
When did Empty EVA Bag receive FDA 510(k) clearance?
Empty EVA Bag received FDA 510(k) clearance on 2021-08-19, under 510(k) number K210749.
Who is the listed applicant for Empty EVA Bag?
The FDA 510(k) record lists Haemotronic S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Empty EVA Bag?
The FDA product code for Empty EVA Bag 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Haemotronic S.P.A.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 AGK252094eZSURE™ 空液容器Epic Medical Pte. , Ltd.K250459DMRX 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.
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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