FDA 510(k) Applications for Medical Device Product Code "ODX"
(Autonomous Extracorporeal Blood Leak Detector/Alarm)

FDA 510(k) Number Applicant Device Name Decision Date
K071013 REDSENSE MEDICAL AB REDSENSE 10/18/2007
K130554 REDSENSE MEDICAL AB REDSENSE ALARM SYSTEM 11/22/2013
K103242 REDSENSE MEDICAL AB REDSENSE-ALARM UNIT AND SENSOR 02/10/2011
K092955 REDSENSE MEDICAL AB REDSENSE-HOME USE 05/10/2010


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