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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 K973596
Device Name SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
Applicant
SPACELABS MEDICAL, INC.
15220 NORTH EAST 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98052
Applicant Contact RUSS GARRISON
Correspondent
SPACELABS MEDICAL, INC.
15220 NORTH EAST 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98052
Correspondent Contact RUSS GARRISON
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received09/22/1997
Decision Date 02/03/1998
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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