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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 K112962
Device Name SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
issaquah,  WA  98029
Applicant Contact davvid j geraghty
Correspondent
SPACELABS MEDICAL INC.
5150 220TH AVE SE
issaquah,  WA  98029
Correspondent Contact davvid j geraghty
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/05/2011
Decision Date 11/02/2011
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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