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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 K951507
Device Name PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE
Applicant
Neuroconcepts, Inc.
2135 Greenview Dr.
Middleton,  WI  53562
Applicant Contact HAO QU
Correspondent
Neuroconcepts, Inc.
2135 Greenview Dr.
Middleton,  WI  53562
Correspondent Contact HAO QU
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received04/03/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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