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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(K) Number K113239
Model HL168KF
Device Name FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
Applicant
HEALTH & LIFE CO., LTD.
9f, no.186, jian yi road
zhonghe district, new taipei, 
Contact sarah su
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/02/2011
Decision Date 03/16/2012
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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