Product code FKT
- Device name
- System, Dialysate Delivery, Sorbent Regenerated
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5600
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset