FDA 510(k) Application Details - K222463

Device Classification Name	More FDA Info for this Device
510(K) Number	K222463
Device Name	EchoGo Heart Failure
Applicant	Ultromics Limited 4630 Kingsgate Cascade Way, Oxford Business Park Oxford OX4 2SU GB Other 510(k) Applications for this Company
Contact	Jaco Jacobs Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2022
Decision Date	11/23/2022
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