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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 K903004
Device Name EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
Applicant
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Applicant Contact ARTHUR BLUMENFELD
Correspondent
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Correspondent Contact ARTHUR BLUMENFELD
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received07/09/1990
Decision Date 11/15/1990
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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