FDA 510(k) Application Details - K102543

Device Classification Name	Electrode, Ph, Stomach   More FDA Info for this Device
510(K) Number	K102543
Device Name	Electrode, Ph, Stomach
Applicant	GIVEN IMAGING LTD. P.O. BOX 258 NEW INDUSTRIAL PARK YOQNEAM 20692 IL Other 510(k) Applications for this Company
Contact	Tim Thomas 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	09/03/2010
Decision Date	12/01/2010
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