K232316
- 510(k) number
- K232316
- Device name
- DEKA Infusion System, DEKA Administration Set
- Applicant
- Deka Research and Development NH · US
- Product code
- LDR — Controller, Infusion, Intravascular, Electronic
- Decision date
- 2024-03-01
- Date received
- 2023-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232316.pdf
Official FDA record: K232316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.