Panels › Gastroenterology, Urology › Product code ODN · Class 2
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Regulation 876.5860
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ODN
| Company | 510(k)s | Recalls |
|---|---|---|
| Nxstage Medical, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 4, 2015 | K150472 | NxStage System One Nxstage Medical, Inc. | ODN |
| Dec 19, 2014 | K141752 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | ODN |
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