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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 K130007
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 Received01/02/2013
Decision Date 04/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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