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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source localization software for electroencephalograph or magnetoencephalograph
510(K) Number K100126
Device Name STELLATE GRIDVIEW
Applicant
EXCEL-TECH LTD. (XLTEK)
2568 bristol cir.
oakville, ontario, 
Contact goldy singh
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Code
LLZ  
Date Received03/10/2010
Decision Date 12/03/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Radiology
statement statement
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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