510(k) K182744

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High by Eurotrol B.V. — Product Code GGM

K182744 is an FDA 510(k) premarket notification submitted by Eurotrol B.V. for the device "HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High". The FDA issued a decision of Substantially Equivalent on February 1, 2019. The device falls under product code GGM (Control, Hemoglobin), a Class II device regulated under 21 CFR 864.8625. Eurotrol B.V. has at least 6 other 510(k) clearances on record.