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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automatic event detection software for polysomnograph with electroencephalograph
510(k) Number K120450
Device Name SLEEP PROFILER
Original Applicant
ADVANCED BRAIN MONITORING, INC.
w324 s3649 county rd e
dousman,  WI  53118
Original Contact adrienne lenz
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received02/14/2012
Decision Date 09/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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