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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced Ejection Fraction Machine Learning-Based Notification Software
510(k) Number K233409
Device Name Eko Low Ejection Fraction Tool (ELEFT)
Applicant
Eko Health, Inc.
2100 Powell St.
Suite 300
Emeryville,  CA  94608
Applicant Contact Sam Huang
Correspondent
Eko Health, Inc.
2100 Powell St.
Suite 300
Emeryville,  CA  94608
Correspondent Contact Sam Huang
Classification Product Code
QYE  
Date Received10/06/2023
Decision Date 03/28/2024
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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