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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 K122196
Device Name CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
Applicant
BLACKROCK NEUROMED, LLC
117 WEST SOUTH STREET
OCONOMOWOC,  WI  53066
Applicant Contact JOHN ZIOBRO
Correspondent
BLACKROCK NEUROMED, LLC
117 WEST SOUTH STREET
OCONOMOWOC,  WI  53066
Correspondent Contact JOHN ZIOBRO
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWK   GWL   OLV  
Date Received07/24/2012
Decision Date 05/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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