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FDA 510(k) Application Details - K123665
Device Classification Name
Non-Normalizing Quantitative Electroencephalograph Software
More FDA Info for this Device
510(K) Number
K123665
Device Name
Non-Normalizing Quantitative Electroencephalograph Software
Applicant
KVIKNA EHF
1468 HARWELL AVE
CROFTON, MD 21114 US
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Contact
YOLANDA SMITH
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLT
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More FDA Info for this Product Code
Date Received
11/28/2012
Decision Date
03/25/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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