510(k) K251937

nordicAudio (1.0) by Nordicneurolab AS — Product Code LNH

K251937 is an FDA 510(k) premarket notification submitted by Nordicneurolab AS for the device "nordicAudio (1.0)". The FDA issued a decision of Substantially Equivalent on March 20, 2026. 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.