FDA 510(k) Application Details - DEN150053

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150053
Device Name	FETAL PILLOW
Applicant	SAFE OBSTETRIC SYSTEMS LTD BERKELEY TOWNSEND 150 HUTTON ROAD SHENFIELD CM15 8NL GB Other 510(k) Applications for this Company
Contact	RAJIV VARMA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2015
Decision Date	07/27/2017
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review