Product code ONW
- Device name
- Hemodialysis System For Home Use
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5860
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To treat and provide hemodialysis therapy at home for chronic renal failure patients.
- Source
- FDA openFDA device classification dataset