FDA 510(k) Application Details - DEN190037

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190037
Device Name	NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
Applicant	AnX Robotica, Inc. 8 The Green, STE A Dover, DE 19901 US Other 510(k) Applications for this Company
Contact	David Duan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2019
Decision Date	05/22/2020
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review