FDA 510(k) Application Details - K172309

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K172309
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	Micro-Tech (Nanjing) CO.,Ltd. No. 10 Gaoke Third Road Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Becky Li 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	07/31/2017
Decision Date	09/29/2017
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