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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 K120727
Model MFM-CMS
Device Name MFM-CMS CENTRAL MONITORING SYSTEM
Original Applicant
EDAN INSTRUMENTS INC
3/f-b, nanshan medical
equipments park
shenzhen,  CH 518067
Original Contact randy jiang
Regulation Number870.1025
Classification Product Code
MHX  
Date Received05/30/2012
Decision Date 06/21/2013
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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