Definition: The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use
| Device Type ID | 2017 |
| Device Name | System, Water Purification, General Medical Use |
| Regulation Description | Water Purification System For Hemodialysis. |
| 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 | 876.5665 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2017 |
| Device | System, Water Purification, General Medical Use |
| Product Code | NHV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Water Purification System For Hemodialysis. |
| CFR Regulation Number | 876.5665 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ECOLAB INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEPHROS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PALL EUROPE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PALL INTERNATIONAL SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 2 |
Material Integrity Problem | 1 |
| Total Device Problems | 3 |