510(k) K071013

Device: REDSENSE
Applicant: REDSENSE MEDICAL AB
510(k) number: K071013
Product code: ODX
Decision: Substantially Equivalent (SESE)
Decision date: 2007-10-18
Date received: 2007-04-10
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: 6470 Riverview Ter. Findley MN US 55432 55432

FDA Registration Numbers#

3013791928
1650907
8030665
3004111573
3015335038
3006948863
1225714
9680579

Source Documents#

Other 510(k) Records For Product Code ODX #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K130554	REDSENSE ALARM SYSTEM	Redsense Medical AB	2013-11-22
K103242	REDSENSE-ALARM UNIT AND SENSOR	Redsense Medical AB	2011-02-10
K092955	REDSENSE-HOME USE	Redsense Medical AB	2010-05-10

Legacy Summary#

summary

FDA Review#

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