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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
Applicant
ANDON HEALTH CO., LTD
No. 3 Jin Ping Street,Ya An Road,
NANKAI DISTRICT
TIANJIN,  CN 300190
Applicant Contact YI LIU
Correspondent
ANDON HEALTH CO., LTD
No. 3 Jin Ping Street,Ya An Road,
NANKAI DISTRICT
TIANJIN,  CN 300190
Correspondent Contact YI LIU
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
MNW  
Date Received07/16/2012
Decision Date 03/21/2013
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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