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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 K242971
Device Name AccurSound Electronic Stethoscope (AS101)
Applicant
Heroic Faith International , Ltd.
18f., # 460, Sec. 4, Xinyi Rd., Xinyi Dist.
Taipei,  TW 110
Applicant Contact Cheng Yuan-Ren
Correspondent
Intellrac, Ltd.
1f., # 4, Aly. 10, Ln. 467, Sec. 2, Zhonghua Rd.
Zhongzheng Dist.
Taipei,  TW 100
Correspondent Contact Tyra Chiu
Regulation Number870.1875
Classification Product Code
DQD  
Date Received09/26/2024
Decision Date 11/25/2024
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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