K232380
- 510(k) number
- K232380
- Device name
- t:slim X2 Insulin Pump with Interoperable Technology
- Applicant
- Tandem Diabetes Care, Inc. CA · US
- Product code
- QFG — Alternate Controller Enabled Insulin Infusion Pump
- Decision date
- 2023-11-03
- Date received
- 2023-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232380.pdf
Official FDA record: K232380
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.