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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K090556
Device Name SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
Applicant
Spacelabs Healthcare Medical Equipment (Suzhou) CO
P.O. Box 3018
Nederland,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
Spacelabs Healthcare Medical Equipment (Suzhou) CO
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number870.1025
Classification Product Code
MHX  
Date Received03/02/2009
Decision Date 04/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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