FDA 510(k) Application Details - K150398

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K150398
Device Name	System, Monitoring, Perinatal
Applicant	OB TOOLS, LTD. MIFALEY HAEMEK INDUSTRIAL ZONE P.O. BOX 667 MIGDAL HA-EMEK 2310502 IL Other 510(k) Applications for this Company
Contact	GAL BEN DAVID 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	02/18/2015
Decision Date	08/06/2015
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