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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K050605
Device Name SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
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 Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DPZ   DQA   DSK   DXG   DXN  
FLL  
Date Received03/10/2005
Decision Date 05/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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