| Device Type ID | 1862 |
| Device Name | Tank, Holding, Dialysis |
| 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) |
| CFR Regulation Number | 876.5820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FIN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1862 |
| Device | Tank, Holding, Dialysis |
| Product Code | FIN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMERIWATER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TANGO3, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Improper Or Incorrect Procedure Or Method | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 2 |