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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K200722
Device Name PCA-C1 series Patient Cable
Applicant
QT Medical, Inc.
1360 Valley Vista Dr.
Suite 203
Diamond Bar,  CA  91765
Applicant Contact Ruey-Kang Chang
Correspondent
QT Medical, Inc.
1360 Valley Vista Dr.
Suite 203
Diamond Bar,  CA  91765
Correspondent Contact Ruey-Kang Chang
Regulation Number870.2900
Classification Product Code
DSA  
Date Received03/19/2020
Decision Date 06/03/2021
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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