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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 K062613
Device Name BIS EEG MONITOR VIEW
Applicant
Aspect Medical Systems, Inc.
One Upland Rd.
Norwood,  MA  02062
Applicant Contact VIKRAM VERMA
Correspondent
Aspect Medical Systems, Inc.
One Upland Rd.
Norwood,  MA  02062
Correspondent Contact VIKRAM VERMA
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received09/05/2006
Decision Date 06/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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