The following data is part of a premarket notification filed by Quanta Dialysis Technologies Ltd with the FDA for Sc+ Hemodialysis Machine, Sc+ Dialysate Cartridge, Sc+ Blood Tubeset.
| Device ID | K210661 |
| 510k Number | K210661 |
| Device Name: | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Quanta Dialysis Technologies Ltd Tything Road Alcester, GB B49 6eu |
| Contact | Sam Drew |
| Correspondent | Sam Drew Quanta Dialysis Technologies Ltd Tything Road Alcester, GB B49 6eu |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-04 |
| Decision Date | 2021-08-12 |