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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 St., Suite 600 & 700
San Fransciso,  CA  94104
Applicant Contact Rosario Iannella
Correspondent
Qardio, Inc.
345 California St., Suite 600 & 700
San Fransciso,  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
Predetermined Change
Control Plan Authorized		 No
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