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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 K120616
Device Name SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
Applicant
SPACELABS MEDICAL, INC.
PO BOX 3018
NEDERLAND,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
SPACELABS MEDICAL, INC.
PO BOX 3018
NEDERLAND,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/29/2012
Decision Date 03/29/2012
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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