FDA 510(k)

HemoTrol WB - 低，HemoTrol WB - 正常，HemoTrol WB - 高

K号: K182744 · 2019-02-01

决定日期2019-02-01

产品代码GGM

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is the device name listed in this FDA 510(k) record. The listed applicant is Eurotrol B.V.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K182744. The device is classified under product code GGM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High?

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Eurotrol B.V.. The 510(k) number is K182744.

When did HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High receive FDA 510(k) clearance?

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182744.

Who is the listed applicant for HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High?

The FDA 510(k) record lists Eurotrol B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High?

The FDA product code for HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is GGM.

列明Eurotrol B.V.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。

K192842HemoTrol Duo低，HemoTrol Duo正常，HemoTrol Duo高 K152553CueSee 缺氧

官方来源

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