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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 K002837
Device Name 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 Received09/12/2000
Decision Date 09/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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