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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 K913051
Device Name SPECTRAL EEG MONITOR MODEL B500
Applicant
BIOMETRAK CORP.
C/O MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact LYNNE ARONSON
Correspondent
BIOMETRAK CORP.
C/O MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact LYNNE ARONSON
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received07/09/1991
Decision Date 08/20/1991
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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