FDA 510(k) Application Details - K113771

Device Classification Name	Cystometric Gas (Carbon-Dioxide) On Hydraulic Device   More FDA Info for this Device
510(K) Number	K113771
Device Name	Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Applicant	NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	CHRISTINE VERGELY Other 510(k) Applications for this Contact
Regulation Number	876.1620   More FDA Info for this Regulation Number
Classification Product Code	FAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2011
Decision Date	12/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review