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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 K052981
Device Name BIS EEG MONITOR, MODEL BISX4
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 DANIEL W LEHTONEN
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received10/24/2005
Decision Date 11/01/2005
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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