K231797
- 510(k) number
- K231797
- Device name
- Medifun Lancing Device, Model No. LD-E1
- Applicant
- Medifun Corporation TW
- Product code
- QRL — Multiple Use Blood Lancet For Single Patient Use Onl
- Decision date
- 2023-11-22
- Date received
- 2023-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K231797.pdf
Official FDA record: K231797
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.