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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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