K241178
- 510(k) number
- K241178
- Device name
- DEKA ACE Pump System
- Applicant
- Deka Research and Development NH · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2024-05-24
- Date received
- 2024-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241178.pdf
Official FDA record: K241178
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.