FDA 510(k) Application Details - K004040

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K004040
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	RED-TECH, INC. 27881 LA PAZ RD. LAGUNA NIGUEL, CA US Other 510(k) Applications for this Company
Contact	GARY MOCNIK 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	12/29/2000
Decision Date	03/29/2001
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