FDA 510(k) Application Details - K954798

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K954798
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. LINCOLN PARK, NJ 07035-1488 US Other 510(k) Applications for this Company
Contact	WILLIAM D HARBESON 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	10/18/1995
Decision Date	06/04/1996
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