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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 K081741
Device Name NEUROLINK IP, MODEL PK1113
Applicant
Excel-Tech Ltd. (Xltek)
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Applicant Contact GOLDY SINGH
Correspondent
Excel-Tech Ltd. (Xltek)
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Correspondent Contact GOLDY SINGH
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received06/19/2008
Decision Date 10/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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