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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 K080546
Device Name NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Applicant Contact JACK COGGAN
Correspondent
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Correspondent Contact JACK COGGAN
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWQ   OLV  
Date Received02/28/2008
Decision Date 08/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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