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Freedom60 Infusion Pump - High-Flo Super26 Subcutaneous Needle Sets
FDA 510(k)Class II (US FDA 510(k))
510(k) K231918
Identifiers
- 510(k) Number
- K231918 FDA 510(k)
- FDA Product Code
- FRN FDA 510(k)
- Models / Variants
- Freedom60 Infusion Pump FDA 510(k)High-Flo Subcutaneous Needle Sets FDA 510(k)Precision Flow Rate Tubing FDA 510(k)High-Flo Super26 Subcutaneous Needle Sets FDA 510(k)Freedom60 Pre-Filled Syringe Adapter FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Freedom60 Infusion Pump - High-Flo Super26 Subcutaneous Needle Sets by Koru Medical Systems — Class II — FDA_510K — listed in FDA 510(k) — 5 models
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 | K231918 | Class II | Active |
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Manufacturer
- Manufacturer
- Koru Medical Systems
Sources (1)
- FDA 510(k) K231918 24 fields · synced Jun 19, 2026