FDA 510(k) Application Details - K160287

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K160287
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	MUI SCIENTIFIC 145 TRADERS BLVD. EAST #33-34 MISSISSAUGA L4Z 3L3 CA Other 510(k) Applications for this Company
Contact	TAMMY MUI 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	02/03/2016
Decision Date	03/14/2017
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