FDA 510(k) Application Details - K955018

Device Classification Name	Electrode, Ph, Stomach   More FDA Info for this Device
510(K) Number	K955018
Device Name	Electrode, Ph, Stomach
Applicant	INSTRUMENTARIUM CORP. ONE FINANCIAL CENTER BOSTON, MA 02111 US Other 510(k) Applications for this Company
Contact	CAROLYN S LANGER Other 510(k) Applications for this Contact
Regulation Number	876.1400   More FDA Info for this Regulation Number
Classification Product Code	FFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/1995
Decision Date	01/30/1996
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