Panels › Gastroenterology, Urology › Product code MQS · Class 2
System, Hemodialysis, Access Recirculation Monitoring
Regulation 876.5820
0510(k)s in 12 months (18 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MQS
| Company | 510(k)s | Recalls |
|---|---|---|
| In-Line Diagnostics Corp. | 5 | 0 |
| Transonic Systems, Inc. | 4 | 1 |
| Hewlett-Packard Co. | 2 | 0 |
| Cobe Renal Care, Inc. | 1 | 0 |
| Dosis, Inc. | 1 | 0 |
| Fresenius USA, Inc. | 1 | 0 |
| H&H Control Systems | 1 | 0 |
| Physician Software Systems, LLC | 1 | 0 |
| Physicians Software Systems, LLC | 1 | 0 |
| Vasc-Alert, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2015 | Transonic Systems Inc Transonic Hemodialysis Monitor, Model HD03 --
Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculat Terminated |
MQS | K960817 |
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