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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K962283
Device Name EEG ELECTRODES
Applicant
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Applicant Contact WILLIAM H BROWN
Correspondent
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Correspondent Contact WILLIAM H BROWN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/13/1996
Decision Date 12/16/1996
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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