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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.
No.32, Keji 1st Rd., Guishan Dist.
Taoyuan,  TW 33383
Applicant Contact Chi-Hsun Hung
Correspondent
Sound Land Corp.
No.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
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