FDA 510(k) Application Details - K180731

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K180731
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	United States Endoscopy Group, Inc. (US Endoscopy) 5976 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Coletta Cohara 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	03/20/2018
Decision Date	04/19/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review