FDA 510(k) Application Details - K103172

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K103172
Device Name	System, Monitoring, Perinatal
Applicant	CIVNET COMMUNICATION LTD Hatamar 58 Moshav Hemed 50295 IL Other 510(k) Applications for this Company
Contact	NATHAN BEN-NATHAN 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	10/28/2010
Decision Date	03/11/2011
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