FDA 510(k) Application Details - K213972

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K213972
Device Name	Computer, Diagnostic, Programmable
Applicant	GE Healthcare Information Technologies, Inc. 9900 Innovation Dr. Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	James T Turner Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2021
Decision Date	02/17/2022
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	Y
Expedited Review