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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 K220466
Device Name ibiomedi Electronic Stethoscope ES-2020
Applicant
Sound Land Corp.
#32, Keji 1st Rd., Guishan Dist.
Taoyuan,  TW 33383
Applicant Contact Chi-Hsun Hung
Correspondent
Sound Land Corp.
#32, Keji 1st Rd., Guishan Dist.
Taoyuan,  TW 33383
Correspondent Contact Chi-Hsun Hung
Regulation Number870.1875
Classification Product Code
DQD  
Date Received02/17/2022
Decision Date 11/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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