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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name non-normalizing quantitative electroencephalograph software
510(k) Number K954157
Device Name DG PORTABLE SYSTEM
Applicant
MEDELEC LTD.
MANOR WAY
OLD WOKING, SURREY,  DE GU22 9JU
Applicant Contact VINCENT MIFSUD
Correspondent
MEDELEC LTD.
MANOR WAY
OLD WOKING, SURREY,  DE GU22 9JU
Correspondent Contact VINCENT MIFSUD
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWQ   OLV  
Date Received09/05/1995
Decision Date 01/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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