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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Full-Montage Electroencephalograph
510(k) Number K120260
Device Name ICTA
Applicant
Excel-Tech Ltd. (Xltek)
2568 Bristol Circle
Oakville,  CA L6H 5S1
Applicant Contact DANIEL RAMIREZ
Correspondent
Excel-Tech Ltd. (Xltek)
2568 Bristol Circle
Oakville,  CA L6H 5S1
Correspondent Contact DANIEL RAMIREZ
Regulation Number882.1400
Classification Product Code
OMB  
Date Received01/27/2012
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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