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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 K213794
Device Name Eko Murmur Analysis Software (EMAS)
Applicant
Eko Devices, Inc.
1212 Broadway, Suite 100
Oakland,  CA  94612
Applicant Contact Sam Huang
Correspondent
Eko Devices, Inc.
1212 Broadway, Suite 100
Oakland,  CA  94612
Correspondent Contact Sam Huang
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DPS  
Date Received12/06/2021
Decision Date 06/29/2022
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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