FDA 510(k) Application Details - K071013

Device Classification Name	Autonomous Extracorporeal Blood Leak Detector/Alarm   More FDA Info for this Device
510(K) Number	K071013
Device Name	Autonomous Extracorporeal Blood Leak Detector/Alarm
Applicant	REDSENSE MEDICAL AB 6470 RIVERVIEW TERRACE FRIDLEY, MN 55432 US Other 510(k) Applications for this Company
Contact	CONSTANCE G BUNDY Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	ODX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2007
Decision Date	10/18/2007
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