FDA 510(k) Application Details - K971913

Device Classification Name	Uroflowmeter   More FDA Info for this Device
510(K) Number	K971913
Device Name	Uroflowmeter
Applicant	ALBYN MEDICAL LTD. BRIDGEND ROAD IND'L ESTATE DINGWALL, ROSS-SHIRE IV15 9QF GB Other 510(k) Applications for this Company
Contact	ROSS K MAXWELL 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	05/22/1997
Decision Date	09/19/1997
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