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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 K171124
Device Name Nihon Kohden Wireless Input Unit WEE-1200
Applicant
Nihon Kohden Corporation
1-31-4 Nisahiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Tom Bento
Correspondent
Nihon Kohden America, Inc.
15353 Barranca Pkwy.
Irvine,  CA  92618
Correspondent Contact Tom Bento
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLV  
Date Received04/17/2017
Decision Date 08/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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