K230083
- 510(k) number
- K230083
- Device name
- SAFIRA
- Applicant
- Medovate Limited GB
- Product code
- FRN — Pump, Infusion
- Decision date
- 2023-10-31
- Date received
- 2023-01-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K230083.pdf
Official FDA record: K230083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.