FDA 510(k) Application Details - K000194

Device Classification Name	Monitor, Penile Tumescence   More FDA Info for this Device
510(K) Number	K000194
Device Name	Monitor, Penile Tumescence
Applicant	UROAN XXI ELECTROMEDICINA C/ ANSELM TURMEDA, 12 PALMA DE MALLORCA BALEARES 07003 ES Other 510(k) Applications for this Company
Contact	VICTORIA GAYA Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2000
Decision Date	04/10/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review