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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K011794
Device Name XLTEK LED GOGGLES, MODEL LED-01
Applicant
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Applicant Contact SONJA MARKEZ
Correspondent
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Correspondent Contact SONJA MARKEZ
Regulation Number882.1890
Classification Product Code
GWE  
Date Received06/08/2001
Decision Date 10/01/2001
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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