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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 K232699
Device Name Low Ejection Fraction AI-ECG Algorithm
Applicant
Anumana, Inc.
One Main Street, Suite 400
East Arcade, 4th Floor
Cambridge,  MA  02142
Applicant Contact Suzanne Goodman
Correspondent
RQM+
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Alexia Haralambous
Classification Product Code
QYE  
Date Received09/05/2023
Decision Date 09/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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