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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K010092
Device Name XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
Applicant
Excel Tech. , Ltd.
2568 Bristol Circle
Oakville,  CA L6H 5S1
Applicant Contact SONJA MARKEZ
Correspondent
Excel Tech. , Ltd.
2568 Bristol Circle
Oakville,  CA L6H 5S1
Correspondent Contact SONJA MARKEZ
Regulation Number882.1870
Classification Product Code
GWF  
Date Received01/11/2001
Decision Date 04/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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