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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 K894088
Device Name TECA NEUROMAPPER 1620, BRAIN MAPPER
Applicant
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Applicant Contact SCOTT A GRILLO
Correspondent
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Correspondent Contact SCOTT A GRILLO
Regulation Number882.1400
Classification Product Code
OLT  
Date Received06/08/1989
Decision Date 11/15/1989
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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