FDA 510(k) Application Details - K964804

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K964804
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	OAKFIELD INSTRUMENTS, LTD. OAKFIELD INDUSTRIAL ESTATE STANTON HARCOURT RD, EYNSHAM OXON OX8 1JA ENGLAND GB Other 510(k) Applications for this Company
Contact	JOHN GIDDINGS 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	11/29/1996
Decision Date	08/06/1997
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