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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K994330
Device Name ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
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 Number882.1320
Classification Product Code
GXY  
Date Received12/23/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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