K230545
- 510(k) number
- K230545
- Device name
- Inessa System
- Applicant
- Triple Jump Israel , Ltd. IL
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2023-12-20
- Date received
- 2023-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K230545.pdf
Official FDA record: K230545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.