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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 K220795
Device Name QT ECG
Applicant
Qt Medical, Inc.
1360 Valley Vista Dr.
Suite 203
Diamond Bar,  CA  91765
Applicant Contact Jackal Chen
Correspondent
Qt Medical, Inc.
1360 Valley Vista Dr.
Suite 203
Diamond Bar,  CA  91765
Correspondent Contact Jackal Chen
Regulation Number870.2920
Classification Product Code
DXH  
Date Received03/18/2022
Decision Date 09/26/2022
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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