FDA 510(k)

°M加热系统及°M站

K号: K260988 · 2026-04-24

决定日期2026-04-24

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 with °M Station 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 2026-04-24 under 510(k) number K260988. 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 with °M Station?

°M Warmer System with °M Station is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Mequ A/S. The 510(k) number is K260988.

When did °M Warmer System with °M Station receive FDA 510(k) clearance?

°M Warmer System with °M Station received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260988.

Who is the listed applicant for °M Warmer System with °M Station?

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 with °M Station?

The FDA product code for °M Warmer System with °M Station is LGZ.

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。

K232107°M 加温系统

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 Medical K252636Fluido 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/S 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。