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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 K052362
Device Name BIS EEG MONITOR, MODEL A-3000
Applicant
ASPECT MEDICAL SYSTEMS, INC.
141 NEEDHAM ST.
NEWTON,  MA  02464
Applicant Contact CHRISTINE VOZELLA
Correspondent
INTERTEK TESTING SERVICES
70 CODMAN HILL RD.
BOXBOROUGH,  MA  01719
Correspondent Contact NEIL E DEVINE
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received08/29/2005
Decision Date 09/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
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