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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 K922548
Device Name MEDELEC 2110 AND 2114 EEG
Applicant
MEDELEC INTL. CORP.
MANOR WAY
OLD WOKING, SURREY GU22 9JU
ENGLAND,  GB
Applicant Contact HOLLOWAY
Correspondent
MEDELEC INTL. CORP.
MANOR WAY
OLD WOKING, SURREY GU22 9JU
ENGLAND,  GB
Correspondent Contact HOLLOWAY
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received06/01/1992
Decision Date 11/03/1992
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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