FDA 510(k) Application Details - K132918

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K132918
Device Name	System, Monitoring, Perinatal
Applicant	SENSE4BABY, INC. 3344 N. TORREY PINES COURT, STE 100 LA JOLLA, CA 92037 US Other 510(k) Applications for this Company
Contact	JACQUES GINESTET 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	09/17/2013
Decision Date	11/22/2013
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