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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 K072286
Device Name BIS EEG VISTA MONITOR SYSTEM AND BISX
Applicant
ASPECT MEDICAL SYSTEMS, INC.
1 UPLAND ROAD
NORWOOD,  MA  02062
Applicant Contact VIKRAM VERMA
Correspondent
ASPECT MEDICAL SYSTEMS, INC.
1 UPLAND ROAD
NORWOOD,  MA  02062
Correspondent Contact VIKRAM VERMA
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received08/16/2007
Decision Date 11/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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