FDA 510(k) Application Details - K233409

Device Classification Name	More FDA Info for this Device
510(K) Number	K233409
Device Name	Eko Low Ejection Fraction Tool (ELEFT)
Applicant	Eko Health, Inc. 2100 Powell Street Suite 300 Emeryville, CA 94608 US Other 510(k) Applications for this Company
Contact	Sam Huang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/06/2023
Decision Date	03/28/2024
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