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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name recorder, magnetic tape, medical
510(k) Number K201644
Device Name QardioCore
Applicant
Qardio Inc.
345 California Street, Suite 600 & 700
san francisco,  CA  94104
Applicant Contact rosario iannella
Correspondent
Qardio Inc.
345 California Street, Suite 600 & 700
san francisco,  CA  94104
Correspondent Contact rosario iannella
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/17/2020
Decision Date 02/28/2021
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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