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510(k) K092955

Device
REDSENSE-HOME USE
Applicant
REDSENSE MEDICAL AB
510(k) number
K092955
Product code
ODX  
Decision
Substantially Equivalent (SESE)
Decision date
2010-05-10
Date received
2009-09-25
Regulation
876.5820
Classification name
Autonomous Extracorporeal Blood Leak Detector/alarm
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CONSTANCE G BUNDY
Address
435 Rice Creek Terrance Fridley MN US 55432 55432

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130554REDSENSE ALARM SYSTEMRedsense Medical AB2013-11-22
K103242REDSENSE-ALARM UNIT AND SENSORRedsense Medical AB2011-02-10
K071013REDSENSERedsense Medical AB2007-10-18

Legacy Summary#

summary

FDA Review#

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