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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2011 | Fresenius Medical Care Holdings, Inc. CombiSet True Flow" 2008K@home Bloodlines
Fresenius Medical Care.
Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra wa Terminated |
ODX | K070049 |
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