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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K201060
Device Name Cordiana Dx16
Cordiana Medical Informatics AG
Platz 4
root,  CH 6039
Applicant Contact johan sandberg
Cordiana Medical Informatics AG
Platz 4
root,  CH 6039
Correspondent Contact johan sandberg
Regulation Number870.1425
Classification Product Code
Date Received04/21/2020
Decision Date 11/16/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No