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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name reduced- montage standard electroencephalograph
510(k) Number K120447
Device Name X4
Original Applicant
w324 s3649 county rd e
dousman,  WI  53118
Original Contact adrienne lenz
Regulation Number882.1400
Classification Product Code
Date Received02/14/2012
Decision Date 06/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No