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AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM - Models- Sys 1000, L3 With N100 Arm, 4b Software
FDA 510(k)Class II (US FDA 510(k))
510(k) K013562
Identifiers
- 510(k) Number
- K013562 FDA 510(k)
- FDA Product Code
- KDI FDA 510(k)
- Models / Variants
- Models- Sys 1000, L3 With N100 Arm, 4b Software FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5860 FDA 510(k)
- Regulation Number
- 876.5860 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM - Models- Sys 1000, L3 With N100 Arm, 4b Software by Baxter Healthcare Corp — Class II…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013562 | Class II | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare Corp
Sources (1)
- FDA 510(k) K013562 24 fields · synced Jun 18, 2026