K240309
- 510(k) number
- K240309
- Device name
- Tandem Mobi insulin pump with interoperable technology
- Applicant
- Tandem Diabetes Care, Inc. CA · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2024-03-21
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240309.pdf
Official FDA record: K240309
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.