FDA 510(k) Application Details - K220732

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K220732
Device Name	System, Monitoring, Perinatal
Applicant	GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Brandon O'Shea Other 510(k) Applications for this Contact
Regulation Number	884.2740   More FDA Info for this Regulation Number
Classification Product Code	HGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2022
Decision Date	06/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review