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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 K250652
Device Name ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Applicant
Anumana, Inc.
One Main St., Suite 400
East Arcade, 4th Floor
Cambridge,  MA  02142
Applicant Contact Taylor Gold West
Correspondent
Anumana, Inc.
One Main St., Suite 400
East Arcade, 4th Floor
Cambridge,  MA  02142
Correspondent Contact Taylor Gold West
Classification Product Code
QYE  
Date Received03/04/2025
Decision Date 07/28/2025
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		 Yes
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