K233044
- 510(k) number
- K233044
- 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
- 2023-10-05
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K233044.pdf
Official FDA record: K233044
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.