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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 K923043
Device Name SPECTRAL EEG MONITOR MODEL A1000
Applicant
ASPECT MEDICAL SYSTEMS, INC.
770 COCHITUATE RD.
P.O. BOX 9331
FRAMINGHAM,  MA  01701
Applicant Contact PAUL J MANBERG
Correspondent
ASPECT MEDICAL SYSTEMS, INC.
770 COCHITUATE RD.
P.O. BOX 9331
FRAMINGHAM,  MA  01701
Correspondent Contact PAUL J MANBERG
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
OMC   ORT  
Date Received06/24/1992
Decision Date 12/03/1992
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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