The following data is part of a premarket notification filed by Dialco Medical Inc. with the FDA for Dimi Rrt System.
| Device ID | K193005 |
| 510k Number | K193005 |
| Device Name: | DIMI RRT System |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Dialco Medical Inc. 135 The West Mall, Unit 2 Toronto, CA M9c1c2 |
| Contact | Danijela Domljanovic |
| Correspondent | Danijela Domljanovic Dialco Medical Inc. 135 The West Mall, Unit 2 Toronto, CA M9c1c2 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-28 |
| Decision Date | 2020-08-28 |