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FDA 510(k) Application Details - K100126
Device Classification Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
More FDA Info for this Device
510(K) Number
K100126
Device Name
Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant
EXCEL-TECH LTD. (XLTEK)
2568 BRISTOL CIR.
OAKVILLE, ONTARIO L6H 5S1 CA
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Contact
GOLDY SINGH
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLX
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More FDA Info for this Product Code
Date Received
01/19/2010
Decision Date
12/03/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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