510(k) K092253

MODIFICATION TO FMRI HARDWARE SYSTEM by Nordicneurolab — Product Code LNH

K092253 is an FDA 510(k) premarket notification submitted by Nordicneurolab for the device "MODIFICATION TO FMRI HARDWARE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 8, 2009. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Nordicneurolab has at least 10 other 510(k) clearances on record.