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FDA 510(k) Application Details - K123079
Device Classification Name
Amplitude-Integrated Electroencephalograph
More FDA Info for this Device
510(K) Number
K123079
Device Name
Amplitude-Integrated Electroencephalograph
Applicant
EXCEL-TECH LTD. (XLTEK)
2568 BRISTOL CIR.
OAKVILLE, ONTARIO L6H 5S1 CA
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Contact
DANIEL RAMIREZ
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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
10/01/2012
Decision Date
05/08/2013
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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