FDA 510(k) Application Details - K220940

Device Classification Name	More FDA Info for this Device
510(K) Number	K220940
Device Name	EchoPAC Software Only, EchoPAC Plug-in
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Tracey Ortiz 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	03/31/2022
Decision Date	07/22/2022
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