Lifemotion 一次性膜式氧合器
K号: K253838 · 2026-03-16
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决定日期2026-03-16
产品代码DTZ
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
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请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
Lifemotion Disposable Membrane Oxygenator is the device name listed in this FDA 510(k) record. The listed applicant is Lifemotion Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253838. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lifemotion Disposable Membrane Oxygenator?
Lifemotion Disposable Membrane Oxygenator is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Lifemotion Medical Technology Co., Ltd.. The 510(k) number is K253838.
When did Lifemotion Disposable Membrane Oxygenator receive FDA 510(k) clearance?
Lifemotion Disposable Membrane Oxygenator received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253838.
Who is the listed applicant for Lifemotion Disposable Membrane Oxygenator?
The FDA 510(k) record lists Lifemotion Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lifemotion Disposable Membrane Oxygenator?
The FDA product code for Lifemotion Disposable Membrane Oxygenator is DTZ.
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。
相关器械（代码：DTZ）
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。
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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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