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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
Applicant Contact CHRISTINE MORGIDA
Correspondent
Aspect Medical Systems, Inc.
2 Vision Dr.
Natick,  MA  01760
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
Predetermined Change
Control Plan Authorized		 No
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