t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater— 510(k) K162080
Substantially EquivalentTandem Diabetes Care, Inc.
FDA 510(k) clearance K162080 for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater, Substantially Equivalent on 2016-10-25. Applicant: Tandem Diabetes Care, Inc..
Clearance details
- Applicant
- Tandem Diabetes Care, Inc.
- Product code
- Code LZG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
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.