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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 K980214
Device Name EXCEL NEURO WORKS
Applicant
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Applicant Contact JOHN R MUMFORD
Correspondent
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Correspondent Contact JOHN R MUMFORD
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received01/21/1998
Decision Date 04/21/1998
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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