FDA 510(k) Application Details - K191087

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K191087
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	AnX Robotica Corp. 7213 Regency Court Plano, TX 75204 US Other 510(k) Applications for this Company
Contact	Lin Wang 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	04/24/2019
Decision Date	12/18/2019
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