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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 K120888
Model PSG-1100
Device Name PSG-1100 SLEEP DIAGNOSTIC SYSTEM
Original Applicant
NIHON KOHDEN CORP.
90 icon street
foothill ranch,  CA  92610
Original Contact steve geerdes
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLV  
Date Received03/23/2012
Decision Date 11/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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