FDA 510(k) Application Details - K181750

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K181750
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	Konsyl Pharmaceuticals 050 Industrial Park Road Easton, MD 21601 US Other 510(k) Applications for this Company
Contact	Frank Gunsallus III 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	07/02/2018
Decision Date	11/15/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review