K234027
- 510(k) number
- K234027
- Device name
- embecta Insulin Delivery System
- Applicant
- Embecta Medical I, LLC MA · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2024-08-30
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K234027.pdf
Official FDA record: K234027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.