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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 K060900
Device Name SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
Applicant
Spacelabs Medical, Inc.
5150 220th Ave. SE
P.O. Box 7018
Issaquah,  WA  98027
Applicant Contact AL VAN HOUDT
Correspondent
Spacelabs Medical, Inc.
5150 220th Ave. SE
P.O. Box 7018
Issaquah,  WA  98027
Correspondent Contact AL VAN HOUDT
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received04/03/2006
Decision Date 06/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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