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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
Predetermined Change
Control Plan Authorized		 Yes
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