用于移植前保存捐赠肝脏的Normothermic机器灌注系统
PMA编号：P200035 · 2026-08-07
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决定日期2026-08-07
PMA 编号P200035
产品代码QQK
设备分类第3类
医疗专科U
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
器械摘要
Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is the device name listed in this FDA 510(k) record. The listed applicant is Organox Limited. It received FDA 510(k) clearance on 2026-08-07. The device is classified under product code QQK. It was reviewed by the GU advisory panel.
常见问题
What is the Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?
Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Organox Limited.
When did Normothermic machine perfusion system for the preservation of donor livers prior to transplantation receive FDA 510(k) clearance?
The clearance date for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation can be found in the official FDA records.
Normothermic machine perfusion system用于在移植前保存捐赠肝脏的申请人是谁？
The FDA 510(k) record lists Organox Limited as the applicant. This does not by itself establish the device manufacturer.
什么是用于在移植前保存捐赠肝脏的常温灌注系统的FDA产品代码？
FDA产品代码为QQK的Normothermic machine perfusion系统用于在移植前保存捐赠的肝脏。
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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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