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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pinwheel
510(k) Number K050313
Device Name BIS SRS (SEMI-RESUABLE SENSOR)
Applicant
Aspect Medical Systems, Inc.
141 Needham St.
Newton,  MA  02464
Applicant Contact CHRISTINE VOZELLA
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Regulation Number882.1750
Classification Product Code
GWY  
Date Received02/09/2005
Decision Date 02/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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