510(k) K191032

fMRI Hardware System by Nordicneurolab AS — Product Code LNH

K191032 is an FDA 510(k) premarket notification submitted by Nordicneurolab AS for the device "fMRI Hardware System". The FDA issued a decision of Substantially Equivalent on November 27, 2019. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Nordicneurolab AS has at least 10 other 510(k) clearances on record.