FDA 510(k) Application Details - K092955

Device Classification Name	Autonomous Extracorporeal Blood Leak Detector/Alarm   More FDA Info for this Device
510(K) Number	K092955
Device Name	Autonomous Extracorporeal Blood Leak Detector/Alarm
Applicant	REDSENSE MEDICAL AB 435 RICE CREEK TERRANCE 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	09/25/2009
Decision Date	05/10/2010
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