FDA 510(k) Application Details - K102801

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K102801
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	E-CATH CO., LTD 13605 WEST 7TH AVENUE GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	ROBERT N CLARK 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	09/27/2010
Decision Date	10/26/2010
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