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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 K103142
Device Name SPACELABS MULTI-PARAMETER MODULE
Applicant
SPACELABS HEALTHCARE, INC.
PO BOX 3018
NEDERLAND,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
SPACELABS HEALTHCARE, INC.
PO BOX 3018
NEDERLAND,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DQA   DSK   DXG   DXN   FLL  
Date Received10/25/2010
Decision Date 03/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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