FDA 510(k)

GEM Premier 5000（测量参数：pH、pCO2和pO2）

K号: K160412 · 2016-12-14

决定日期2016-12-14

产品代码CHL

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

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K160412. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)?

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160412.

When did GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) receive FDA 510(k) clearance?

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) received FDA 510(k) clearance on 2016-12-14, under 510(k) number K160412.

Who is the listed applicant for GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)?

The FDA product code for GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) is CHL.

列明Instrumentation Laboratory CO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。

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