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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 K210179
Device Name QOCA Portable ECG Monitoring Device
Applicant
Quanta Computer Inc.
No. 188, Wenhua 2nd Road, Guishan District
Taoyuan City,  TW 33377
Applicant Contact Vivian Yang
Correspondent
Quanta Computer Inc.
No. 188, Wenhua 2nd Road, Guishan District
Taoyuan City,  TW 33377
Correspondent Contact Vivian Yang
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Code
DXH  
Date Received01/22/2021
Decision Date 08/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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