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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K131383
Device Name X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
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
GWQ  
Subsequent Product Code
OMC  
Date Received05/14/2013
Decision Date 11/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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