FDA 510(k)

ABL90 FLEX，ABL90 FLEX PLUS

K号: K170882 · 2017-04-28

决定日期2017-04-28

产品代码MQM

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

ABL90 FLEX, ABL90 FLEX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170882. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ABL90 FLEX, ABL90 FLEX PLUS?

ABL90 FLEX, ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Radiometer Medical Aps. The 510(k) number is K170882.

When did ABL90 FLEX, ABL90 FLEX PLUS receive FDA 510(k) clearance?

ABL90 FLEX, ABL90 FLEX PLUS received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170882.

Who is the listed applicant for ABL90 FLEX, ABL90 FLEX PLUS?

The FDA 510(k) record lists Radiometer Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABL90 FLEX, ABL90 FLEX PLUS?

The FDA product code for ABL90 FLEX, ABL90 FLEX PLUS is MQM.

列明Radiometer Medical Aps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。

K163462AQT90 FLEX 肌酸激酶MB（CKMB）测试套件，AQT90 FLEX K160153ABL90 FLEX PLUS

官方来源

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