FDA 510(k) Application Details - K062362

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K062362
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	SARMED SRL VIA DEGLI ARTIGIANI, 6 MEDOLLA 41036 IT Other 510(k) Applications for this Company
Contact	ANTONIO ROSSETTI 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	08/14/2006
Decision Date	04/13/2007
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