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Sleep Performance D.B.A. Fatigue Science
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SBV2, MULTICHARGER MODEL MC10V2 is an FDA 510(k)-cleared medical device (K111514) manufactured by Sleep Performance D.B.A. Fatigue Science. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2011. Regulation: 8.