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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 K850430
Device Name NEUROSCIENCE MAP-10 EEG
Applicant
NEUROSCIENCE, INC.
4916 EL CAMINO REAL
LOS ALTOS,  CA  94022
Applicant Contact ANTHONY DEPALMA
Correspondent
NEUROSCIENCE, INC.
4916 EL CAMINO REAL
LOS ALTOS,  CA  94022
Correspondent Contact ANTHONY DEPALMA
Regulation Number882.1420
Classification Product Code
GWS  
Date Received02/04/1985
Decision Date 07/17/1985
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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