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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
PO BOX 7018
ISSAQUAH, WA,  WA  98027 -7018
Applicant Contact AL VAN HOUDT
Correspondent
SPACELABS MEDICAL INC.
5150 220TH AVE SE
PO BOX 7018
ISSAQUAH, WA,  WA  98027 -7018
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
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