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FDA 510(k)

空Eva袋，型号FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

K号: K181393 · 2019-02-15

申请人Valmed S.R.L.
决定日期2019-02-15
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, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP is the device name listed in this FDA 510(k) record. The listed applicant is Valmed S.R.L.. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K181393. 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, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP?

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Valmed S.R.L.. The 510(k) number is K181393.

When did Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP receive FDA 510(k) clearance?

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP received FDA 510(k) clearance on 2019-02-15, under 510(k) number K181393.

Who is the listed applicant for Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP?

The FDA 510(k) record lists Valmed S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP?

The FDA product code for Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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

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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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