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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal
510(k) Number K844481
Device Name NEUROLAB II
Applicant
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Applicant Contact EDWARD R SIROIS
Correspondent
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Correspondent Contact EDWARD R SIROIS
Regulation Number882.1420
Classification Product Code
GWS  
Date Received11/19/1984
Decision Date 05/20/1985
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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