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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
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