FDA 510(k) Application Details - DEN130040

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130040
Device Name	IOGYN SYSTEM
Applicant	IOGYN, INC. 20195 STEVENS CREEK BOULEVARD SUITE 120 CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	MARY EDWARDS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2013
Decision Date	03/28/2014
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