
Elekta Neuromag OY
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ELEKTA NEUROMAG WITH MAXFILTER is an FDA 510(k)-cleared medical device (K091393) manufactured by Elekta Neuromag OY. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 2010. Regulation: 8.