K231519
- 510(k) number
- K231519
- Device name
- Revital Cady
- Applicant
- Revital Healthcare (Epz) Limited KE
- Product code
- FMF — Syringe, Piston
- Decision date
- 2023-11-06
- Date received
- 2023-05-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231519.pdf
Official FDA record: K231519
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.