FDA 510(k) Application Details - K141848

Device Classification Name	More FDA Info for this Device
510(K) Number	K141848
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	RICH CHRISTENSEN 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	07/09/2014
Decision Date	08/29/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review