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FDA 510(k) Application Details - K120485
Device Classification Name
Amplitude-Integrated Electroencephalograph
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510(K) Number
K120485
Device Name
Amplitude-Integrated Electroencephalograph
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH, CA 92610-1601 US
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Contact
STEVE GEERDES
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Regulation Number
882.1400
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Classification Product Code
OMA
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More FDA Info for this Product Code
Date Received
02/17/2012
Decision Date
03/16/2012
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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