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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 K230111
Device Name CORE 500 Digital Stethoscope
Applicant
Eko Devices, Inc.
1212 Broadway, Suite 100
Oakland,  CA  94612
Applicant Contact Sam Huang, Ph.D.
Correspondent
Eko Devices, Inc.
1212 Broadway, Suite 100
Oakland,  CA  94612
Correspondent Contact Sam Huang, Ph.D.
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DPS  
Date Received01/17/2023
Decision Date 05/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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