FDA 510(k) Application Details - K142147

Device Classification Name	More FDA Info for this Device
510(K) Number	K142147
Device Name	EEVA SYSTEM
Applicant	AUXOGYN, INC. 1490 O'BRIEN DRIVE, SUITE A MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	JULIA S ANASTAS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2014
Decision Date	11/24/2014
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