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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 K110376
Device Name PE-210AK SWITCH BOX
Applicant
NIHON KOHDEN CORP.
90 ICON STREET
FOOTHILL RANCH,  CA  92610
Applicant Contact STEVE GEERDES
Correspondent
NIHON KOHDEN CORP.
90 ICON STREET
FOOTHILL RANCH,  CA  92610
Correspondent Contact STEVE GEERDES
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GYC  
Date Received02/09/2011
Decision Date 07/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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