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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 K140067
Device Name QARDIOARM
Applicant
QARDIO, INC.
340 s lemon ave #1104f
walnut,  CA  91789
Applicant Contact jen ke-min
Correspondent
QARDIO, INC.
340 s lemon ave #1104f
walnut,  CA  91789
Correspodent Contact jen ke-min
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/10/2014
Decision Date 06/18/2014
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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