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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 K093501
Device Name ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
Applicant
Spacelabs Medical, Inc.
5150 220th Ave. SE
Issaquah,  WA  98029
Applicant Contact DAVID GERAGHTY
Correspondent
Spacelabs Medical, Inc.
5150 220th Ave. SE
Issaquah,  WA  98029
Correspondent Contact DAVID GERAGHTY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received11/12/2009
Decision Date 11/24/2009
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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