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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K062692
Device Name BIS BILATERAL SENSOR
Applicant
Aspect Medical Systems, Inc.
141 Needham St.
Newton,  MA  02464
Applicant Contact RENEE GOULD
Correspondent
Aspect Medical Systems, Inc.
141 Needham St.
Newton,  MA  02464
Correspondent Contact RENEE GOULD
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/11/2006
Decision Date 12/13/2006
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
Recalls CDRH Recalls
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