FDA 510(k) Application Details - K134026

Device Classification Name	More FDA Info for this Device
510(K) Number	K134026
Device Name	ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
Applicant	OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 CENTER VALLEY, PA 18034-0610 US Other 510(k) Applications for this Company
Contact	DAPHNEY GERMAIN-KOLAWOLE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2013
Decision Date	03/07/2014
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