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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 K233521
Device Name QT ECG (QTERD100)
Applicant
QT Medical, Inc.
1370 Valley Vista Dr. Suite 266
Diamond Bar,  CA  91765
Applicant Contact Jui-Hung Hung
Correspondent
QT Medical, Inc.
1370 Valley Vista Dr. Suite 266
Diamond Bar,  CA  91765
Correspondent Contact Jui-Hung Hung
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DRX  
Date Received11/01/2023
Decision Date 12/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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