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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stethoscope, electronic
510(k) Number K221805
Device Name AccurSound Electronic Stethoscope AS-101
Applicant
Heroic Faith International Ltd.
18F., No. 460, Section 4, Xinyi Road, Xinyi District
Taipei City,  TW 110
Applicant Contact Yuan-Ren Cheng
Correspondent
Heroic Faith International Ltd.
18F., No. 460, Section 4, Xinyi Road, Xinyi District
Taipei City,  TW 110
Correspondent Contact Yuan-Ren Cheng
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/22/2022
Decision Date 03/23/2023
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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