The following data is part of a premarket notification filed by Quanta Dialysis Technologies Ltd. with the FDA for Sc+ Haemodialysis Machine, Sc+ Dialysate Cartridge, Sc+ Blood Tube Set.
| Device ID | K193670 |
| 510k Number | K193670 |
| Device Name: | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Quanta Dialysis Technologies Ltd. Tything Road Alcester, GB B49 6eu |
| Contact | Chris Rule |
| Correspondent | Chris Rule 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 | 2019-12-31 |
| Decision Date | 2020-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060497260092 | K193670 | 000 |
| 05060497260030 | K193670 | 000 |
| 05060497260023 | K193670 | 000 |