FDA 510(k) Application Details - K013704

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K013704
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	MEDIPLUS LTD. 541 MORENO CIRCLE NE ST. PETERSBURG, FL 33703 US Other 510(k) Applications for this Company
Contact	ELIZABETH M PAUL Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	KLA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2001
Decision Date	08/05/2002
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