°M 加温系统
K号: K232107 · 2024-05-31
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申请人Mequ A/S
决定日期2024-05-31
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
°M Warmer System is the device name listed in this FDA 510(k) record. The listed applicant is Mequ A/S. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232107. 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 °M Warmer System?
°M Warmer System is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Mequ A/S. The 510(k) number is K232107.
When did °M Warmer System receive FDA 510(k) clearance?
°M Warmer System received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232107.
Who is the listed applicant for °M Warmer System?
The FDA 510(k) record lists Mequ A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for °M Warmer System?
The FDA product code for °M Warmer System 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Mequ A/S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)K211618Fluido Compact 血液和液体加温系统The Surgical Company International B.V.K211800战士血液和液体加热器，战士EXTREME血液和液体加热器，战士轻量血液和液体加热器Quality IN Flow , 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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