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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name cranial motion measurement device
De Novo Number DEN140040
Device Name Nautilus BrainPulse 1000
110 pioneer way, suite l
mountain view,  CA  94041
Contact paul lovoi
Regulation Number882.1630
Classification Product Code
Date Received12/23/2014
Decision Date 08/01/2016
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct