HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
K-Number: K182744 · 2019-02-01
ApplicantEurotrol B.V.
Decision Date2019-02-01
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is a medical device manufactured by Eurotrol B.V.. It received FDA 510(k) clearance on 2019-02-01 under approval number K182744. 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 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. It is manufactured by Eurotrol B.V.. The 510(k) number is K182744.
When was HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High approved by the FDA?
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High received FDA 510(k) clearance on 2019-02-01, under approval number K182744.
What company makes HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High?
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High is manufactured by Eurotrol B.V..
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.
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.