The following data is part of a premarket notification filed by Baxter Healthcare Corportation with the FDA for Ak 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory.
| Device ID | K201809 |
| 510k Number | K201809 |
| Device Name: | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Baxter Healthcare Corportation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Contact | Kristen Bozzelli |
| Correspondent | Kristen Bozzelli Baxter Healthcare Corportation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Product Code | KDI |
| Subsequent Product Code | FIP |
| Subsequent Product Code | FJK |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2021-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332414124519 | K201809 | 000 |
| 37332414102501 | K201809 | 000 |
| 37332414004096 | K201809 | 000 |