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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 K002332
Device Name EEG SPIKE AND EVENT DETECTOR MODULE
Applicant
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Applicant Contact DEBBIE DAVY
Correspondent
Excel Tech. , Ltd.
2568 Bristol Cir.
Oakville,  CA L6H 5S1
Correspondent Contact DEBBIE DAVY
Regulation Number882.1400
Classification Product Code
OMB  
Date Received08/01/2000
Decision Date 10/06/2000
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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