| Device |
hemodialysis system for home use |
| Regulation Description |
High permeability hemodialysis system. |
| Definition |
To treat and provide hemodialysis therapy at home for chronic renal failure patients. |
| Physical State |
Complex machine consisting of pumps, monitors, and tubing. |
| Technical Method |
A machine that dialyzes the patient's blood. |
| Target Area |
Connects to the patient's blood stream |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | ONW |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5860
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
