FDA 510(k) Application Details - K201106

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K201106
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	AnX Robotica Corp. 1047 Serpentine Ln. Suite 100, Pleasanton Pleasanton, CA 94566 US Other 510(k) Applications for this Company
Contact	Steven Gu Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2020
Decision Date	05/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review