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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K011204
Device Name NEUROFAX, MODELS EEG-1100A, EEG-9100A
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Applicant Contact BONNIE BISHOP
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent Contact BONNIE BISHOP
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received04/19/2001
Decision Date 05/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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