FDA 510(k) Application Details - K142425

Device Classification Name	Uroflowmeter   More FDA Info for this Device
510(K) Number	K142425
Device Name	Uroflowmeter
Applicant	BE TECHNOLOGIES, INC. 2939 20th Avenue San Francisco, CA 94132 US Other 510(k) Applications for this Company
Contact	Edward Belotserkovsky Other 510(k) Applications for this Contact
Regulation Number	876.1800   More FDA Info for this Regulation Number
Classification Product Code	EXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2014
Decision Date	10/27/2014
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