FDA 510(k) Application Details - K162447

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K162447
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	PENTAX of America, Inc. 3 Paragon Drive Montvale, NJ 07645-1782 US Other 510(k) Applications for this Company
Contact	Krishna Govindarajan 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	09/01/2016
Decision Date	04/13/2017
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