The following data is part of a premarket notification filed by Baxter Healthcare Corp with the FDA for Prismax Control Unit.
| Device ID | K163530 |
| 510k Number | K163530 |
| Device Name: | PrisMax Control Unit |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORP 7601 Northland Drive Suite 170 Brooklyn Park, MN 55428 |
| Contact | Chris Scavotto |
| Correspondent | Chris Scavotto BAXTER HEALTHCARE CORP 7601 Northland Drive Suite 170 Brooklyn Park, MN 55428 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-05-03 |
| Summary: | summary |