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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 K122098
Device Name APPS-HEALTH01
Original Applicant
no. 3 jin ping street,ya an road,
nankai district
tianjin,  CN 300190
Original Contact yi liu
Regulation Number870.1130
Classification Product Code
Subsequent Product Code
Date Received07/16/2012
Decision Date 03/21/2013
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