FDA 510(k) Application Details - K210791

Device Classification Name	More FDA Info for this Device
510(K) Number	K210791
Device Name	Us2.v1
Applicant	eko.ai Pte. Ltd. d/b/a Us2.ai 2 College Road, #02-00 Singapore 94080 SG Other 510(k) Applications for this Company
Contact	James Hare Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2021
Decision Date	07/27/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review