K233952
- 510(k) number
- K233952
- Device name
- DEKA ACE Pump System
- Applicant
- Deka Research and Development NH · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2024-03-13
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233952.pdf
Official FDA record: K233952
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.