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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K082886
Device Name ZOOM-100DC
Applicant
Brainscope Company, Inc.
1717 Rhode Island Ave.
9th Floor
Washington,  DC  20036
Applicant Contact MICHAEL E SINGER
Correspondent
Brainscope Company, Inc.
1717 Rhode Island Ave.
9th Floor
Washington,  DC  20036
Correspondent Contact MICHAEL E SINGER
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received09/30/2008
Decision Date 08/10/2009
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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