The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Aurora System 1000 Series Home Self-care Single Patient Delivery System; Models- Sys 1000, L3 With N100 Arm, 4b Software.
| Device ID | K013562 |
| 510k Number | K013562 |
| Device Name: | AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mc Gaw Park, IL 60085 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mc Gaw Park, IL 60085 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-26 |
| Decision Date | 2002-12-12 |
| Summary: | summary |