t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)— 510(k) K203234
Substantially EquivalentTandem Diabetes Care, Inc.
FDA 510(k) clearance K203234 for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app), Substantially Equivalent on 2022-02-15. Applicant: Tandem Diabetes Care, Inc..
Clearance details
- Applicant
- Tandem Diabetes Care, Inc.
- Product code
- Code QFG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code QFG
product code QFG- Death
- 228
- Injury
- 118,915
- Malfunction
- 1,001,752
- Other
- 7
- Total
- 1,120,902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.