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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name index-generating electroencephalograph software
510(k) Number K963644
Device Name A-1000 EEG MONITOR AND A-1050 EEG MONITOR
Applicant
ASPECT MEDICAL SYSTEMS, INC.
2 VISION DR.
NATICK,  MA  01760 -2059
Applicant Contact CHRISTINE MORGIDA
Correspondent
ASPECT MEDICAL SYSTEMS, INC.
2 VISION DR.
NATICK,  MA  01760 -2059
Correspondent Contact CHRISTINE MORGIDA
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received09/12/1996
Decision Date 10/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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