FDA 510(k) Application Details - K061068

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K061068
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. MONTVALE, NJ 07645-1856 US Other 510(k) Applications for this Company
Contact	PAUL SILVA Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2006
Decision Date	05/03/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review