FDA 510(k) Application Details - K122294

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K122294
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	MUI SCIENTIFIC 145 TRADERS BLVD. EAST, # 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	07/31/2012
Decision Date	11/01/2012
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