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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
Applicant
Advanced Brain Monitoring, Inc.
W324 S3649 County Rd. E
Dousman,  WI  53118
Applicant Contact ADRIENNE LENZ
Correspondent
Advanced Brain Monitoring, Inc.
W324 S3649 County Rd. E
Dousman,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received02/14/2012
Decision Date 09/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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