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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 K820066
Device Name ELECTROENCEPHALOGRAPHS EEG-5208,5210
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received01/11/1982
Decision Date 02/04/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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