HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K-Number: K192842 · 2019-11-15
ApplicantEurotrol B.V.
Decision Date2019-11-15
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High is a medical device manufactured by Eurotrol B.V.. It received FDA 510(k) clearance on 2019-11-15 under approval number K192842. The device is classified under product code GGM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Eurotrol B.V.. The 510(k) number is K192842.
When was HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High approved by the FDA?
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High received FDA 510(k) clearance on 2019-11-15, under approval number K192842.
What company makes HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High?
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High is manufactured by Eurotrol B.V..
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.
Other Devices by Eurotrol B.V.
Related Devices (Code: GGM)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.