FDA 510(k) Application Details - K232699

Device Classification Name	More FDA Info for this Device
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 US Other 510(k) Applications for this Company
Contact	Suzanne Goodman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2023
Decision Date	09/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review