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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 K120485
Device Name NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
Original Applicant
NIHON KOHDEN AMERICA, INC.
90 icon st.
foothill ranch,  CA  92610 -1601
Original Contact steve geerdes
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OLT   ORT  
Date Received02/17/2012
Decision Date 03/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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