FDA 510(k) Application Details - K241368

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K241368
Device Name	System, Monitoring, Perinatal
Applicant	Huntleigh Healthcare Ltd. 35 Portmanmoor Road Cardiff CF24 5HN GB Other 510(k) Applications for this Company
Contact	Steve Monks 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	05/14/2024
Decision Date	02/03/2025
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	Y
Expedited Review