FDA 510(k) Application Details - K241009

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K241009
Device Name	System, Monitoring, Perinatal
Applicant	PeriGen, Inc. Sderot Nim 2 PO Box 110 Rishon LeTziyon 7510002 IL Other 510(k) Applications for this Company
Contact	Alva Candace 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	04/12/2024
Decision Date	01/10/2025
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	N
Expedited Review