510(k) K081430

ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING by Elekta Neuromag OY — Product Code OLX

K081430 is an FDA 510(k) premarket notification submitted by Elekta Neuromag OY for the device "ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING". The FDA issued a decision of Substantially Equivalent on July 28, 2008. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Elekta Neuromag OY has at least 3 other 510(k) clearances on record.