FDA 510(k) Application Details - K214089

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K214089
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun 258-8538 JP Other 510(k) Applications for this Company
Contact	Randy Vader 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	12/28/2021
Decision Date	06/03/2022
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	N
Expedited Review