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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
Applicant
BIONET CO., LTD.
2600 MISSION ST., SUITE 100
SAN MARINO,  CA  91108
Applicant Contact YINGCHAO XIAO
Correspondent
BIONET CO., LTD.
2600 MISSION ST., SUITE 100
SAN MARINO,  CA  91108
Correspondent Contact YINGCHAO XIAO
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/15/2008
Decision Date 12/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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