Panels › Gastroenterology, Urology › Product code ODX · Class 2
Autonomous Extracorporeal Blood Leak Detector/Alarm
Regulation 876.5820
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in ODX
| Company | 510(k)s | Recalls |
|---|---|---|
| Redsense Medical AB | 4 | 0 |
| Fresenius Medical Care Holdings, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 2013 | K130554 | REDSENSE ALARM SYSTEM Redsense Medical AB, SE | ODX |
| Feb 10, 2011 | K103242 | REDSENSE-ALARM UNIT AND SENSOR Redsense Medical AB | ODX |
| May 10, 2010 | K092955 | REDSENSE-HOME USE Redsense Medical AB | ODX |
| Oct 18, 2007 | K071013 | REDSENSE Redsense Medical AB | ODX |
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