QiF 血液和液体加热器
K号: K150404 · 2016-06-23
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决定日期2016-06-23
产品代码LGZ
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
QiF Blood and Fluid Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Quality IN Flow , Ltd.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K150404. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the QiF Blood and Fluid Warmer?
QiF Blood and Fluid Warmer is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Quality IN Flow , Ltd.. The 510(k) number is K150404.
When did QiF Blood and Fluid Warmer receive FDA 510(k) clearance?
QiF Blood and Fluid Warmer received FDA 510(k) clearance on 2016-06-23, under 510(k) number K150404.
Who is the listed applicant for QiF Blood and Fluid Warmer?
The FDA 510(k) record lists Quality IN Flow , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QiF Blood and Fluid Warmer?
The FDA product code for QiF Blood and Fluid Warmer is LGZ.
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Quality IN Flow , 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：LGZ）
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。
K262532NORMOFLO™ 灌洗液加温套装及配件（IR-601，IR-501，IR-61，PL-61）ICU MedicalK260988°M加热系统及°M站Mequ A/SK252636Fluido Compact 系统The Surgical Company International B.V.K251733Fluido® AirGuard 系统The Surgical Company International BV (As Tsc Life)K232107°M 加温系统Mequ A/SK211618Fluido Compact 血液和液体加温系统The Surgical Company International B.V.
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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