FDA 510(k) Application Details - K250151

Device Classification Name	More FDA Info for this Device
510(K) Number	K250151
Device Name	Us2.ca
Applicant	Eko.ai Pte. Ltd. d/b/a Us2.ai 2 College Road, 02-00 Singapore 169850 SG Other 510(k) Applications for this Company
Contact	Hui Qun Tay Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2025
Decision Date	06/20/2025
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