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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
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