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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 K122146
Model 96102
Device Name XHIBIT CENTRAL STATION, MODEL 96102
Original Applicant
SPACELABS HEALTHCARE
p.o. box 3018
nederland,  CO  80466
Original Contact thomas kroenke
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSI   MLD   MSX  
Date Received07/19/2012
Decision Date 04/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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