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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 K011534
Device Name EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
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 Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received05/18/2001
Decision Date 06/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
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