FDA 510(k)

HemoTrol Duo低，HemoTrol Duo正常，HemoTrol Duo高

K号: K192842 · 2019-11-15

决定日期2019-11-15

产品代码GGM

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决定实质等同

器械摘要

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo 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 2019-11-15 under 510(k) number K192842. 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 Duo Low, HemoTrol Duo Normal, HemoTrol Duo High?

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Eurotrol B.V.. The 510(k) number is K192842.

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

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192842.

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

The FDA product code for HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo 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。

K182744HemoTrol WB - 低，HemoTrol WB - 正常，HemoTrol WB - 高 K152553CueSee 缺氧

官方来源

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