FDA 510(k) Application Details - K983665

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K983665
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	DENTSLEEVE PTY., LTD. 56 A/B GLEN OSMOND RD. PARKSIDE SOUTH AUSTRALIA 5063 AU Other 510(k) Applications for this Company
Contact	MARCUS TIPPETT 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	10/19/1998
Decision Date	05/17/1999
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