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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K163644
Device Name Nihon Kohden QP-160AK EEG Trend Program
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Tom Bento
Correspondent
Nihon Kohden America, Inc.
15353 Barranca Pkwy.
Rvine,  CA  92618
Correspondent Contact Tom Bento
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OLT   OMB   ORT  
Date Received12/23/2016
Decision Date 05/19/2017
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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