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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 K153412
Device Name Sleep Profiler
Applicant
Advanced Brain Monitoring, Inc.
2237 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Applicant Contact DANIEL J. LEVENDOWSKI
Correspondent
Pathway Regulatory Consulting, LLC
W324 S3649 County Rd. E
Dousman,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received11/25/2015
Decision Date 03/14/2016
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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