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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K042150
Device Name XLTEK TREX MODEL#10309
Applicant
Excel Tech. , Ltd.
2568 Bristol Circle
Oakville,  CA L6H 5S1
Applicant Contact NICOLE LANDREVILLE
Correspondent
Excel Tech. , Ltd.
2568 Bristol Circle
Oakville,  CA L6H 5S1
Correspondent Contact NICOLE LANDREVILLE
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received08/09/2004
Decision Date 08/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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