FDA 510(k) Application Details - K231964

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K231964
Device Name	System, Monitoring, Perinatal
Applicant	Datex Ohmeda 9900 Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Isabel McGann 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	07/03/2023
Decision Date	12/08/2023
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