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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood pressure cuff
510(K) Number K122259
Model HBPK-A
Device Name BLOOD PRESSURE MONITOR WITH STETHOSCOPE
Applicant
HANGZHOU RELI-ON CO., LTD
77325 joyce way
echo,  OR  97826
Contact charile mack
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/27/2012
Decision Date 09/24/2012
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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