t:slim X2 insulin pump with interoperable technology— 510(k) DEN180058
UnknownTandem Diabetes Care, Inc.
FDA 510(k) clearance DEN180058 for t:slim X2 insulin pump with interoperable technology, Unknown on 2019-02-14. Applicant: Tandem Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Tandem Diabetes Care, Inc.
- Product code
- Code QFG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5730
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- San Diego, CA, US
Recent devices under product code QFG
view allMore clearances from Tandem Diabetes Care, Inc.
view allAdverse 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.