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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K260250
Device Name QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
Applicant
QT Medical, Inc.
1370 Valley Vista Dr. Suite 266
Diamond Bar,  CA  91765
Applicant Contact Irving Yu
Correspondent
QT Medical, Inc.
1370 Valley Vista Dr. Suite 266
Diamond Bar,  CA  91765
Correspondent Contact Irving Yu
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DSA  
Date Received01/27/2026
Decision Date 09/29/2026
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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