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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(without arrhythmia detection or alarms)
510(k) Number K113833
Model M900, V6
Device Name VITAL SIGNS MONITOR
Original Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD
p.o. box 237-023
shanghai,  CH 200237
Original Contact diana hong
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/27/2011
Decision Date 05/01/2012
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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