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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K182396
Device Name KardiaMobile, KardiaStation
Applicant
AliveCor, Inc.
444 Castro Street, Suite 600
mountain view,  CA  94041
Applicant Contact prabhu raghavan
Correspondent
AliveCor, Inc.
444 Castro Street, Suite 600
mountain view,  CA  94041
Correspondent Contact prabhu raghavan
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DPH  
Date Received09/04/2018
Decision Date 04/12/2019
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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