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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 K120173
Model RLITE V8
Device Name PATIENT MONITOR
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  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
DQA   DRT   DSA   DSI   DSK   DXN  
FLL   MLD  
Date Received01/20/2012
Decision Date 05/16/2012
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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