FDA 510(k) Application Details - K010591

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K010591
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	OLYMPUS OPTICAL CO., LTD. 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JP Other 510(k) Applications for this Company
Contact	TSUYOSHI YANAI 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	02/28/2001
Decision Date	03/15/2001
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