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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
Correspondent 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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