K231918
- 510(k) number
- K231918
- Device name
- Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
- Applicant
- Koru Medical Systems NJ · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2023-11-03
- Date received
- 2023-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K231918.pdf
Official FDA record: K231918
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.