| Device Type ID | 2002 |
| Device Name | System, Hemodialysis, Remote Accessories |
| Regulation Description | Hemodialysis System And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MON |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2002 |
| Device | System, Hemodialysis, Remote Accessories |
| Product Code | MON |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 7 |
Disconnection | 5 |
Fluid Leak | 3 |
| Total Device Problems | 15 |