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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 K082008
Device Name BIONET BM3PLUS PATIENT MONITOR
Original Applicant
BIONET CO., LTD.
2600 mission st., suite 100
san marino,  CA  91108
Original Contact yingchao xiao
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/15/2008
Decision Date 12/11/2008
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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