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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 K261694
Device Name CORE 300 Digital Stethoscope
Applicant
Eko Health, Inc.
2100 Powell St.
Suite 300
Emeryville,  CA  94608
Applicant Contact Min Cao
Correspondent
Eko Health, Inc.
2100 Powell St.
Suite 300
Emeryville,  CA  94608
Correspondent Contact Min Cao
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/22/2026
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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