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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 K092573
Device Name NIHON KOHDEN QP-160AK EEG TREND PROGRAM
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Applicant Contact STEVE GEERDES
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Correspondent Contact STEVE GEERDES
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OLT   ORT  
Date Received08/20/2009
Decision Date 07/09/2010
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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