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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
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Tom Bento
Nihon Kohden America, Inc.
15353 Barranca Parkway
Irvine,  CA  92618
Correspondent Contact Tom Bento
Regulation Number882.1400
Classification Product Code
Subsequent Product Codes
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