
Eb Neuro S.P.A.
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MIZAR, BASIS BE, SANDMAN DIGITAL is an FDA 510(k)-cleared medical device (K003154) manufactured by Eb Neuro S.P.A.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2001. Regulation: 8.