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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 K001980
Device Name ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
Applicant
ASPECT MEDICAL SYSTEMS, INC.
141 NEEDHAM ST.
NEWTON,  MA  02464
Applicant Contact CHRISTINE M VOZELLA
Correspondent
ASPECT MEDICAL SYSTEMS, INC.
141 NEEDHAM ST.
NEWTON,  MA  02464
Correspondent Contact CHRISTINE M VOZELLA
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/29/2000
Decision Date 09/27/2000
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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