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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 K121025
Device Name YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION
Original Applicant
YA HORNG ELECTRONIC CO., LTD.
no. 58, fu-chiun st.
hsin-chu city,  TW 30067
Original Contact jen ke-min
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/04/2012
Decision Date 08/17/2012
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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