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FDA 510(k) Application Details - K113117
Device Classification Name
Electroencephalograph
More FDA Info for this Device
510(K) Number
K113117
Device Name
Electroencephalograph
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH, CA 92610-1601 US
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Contact
STEVE GEERDES
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
GWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2011
Decision Date
03/22/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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