Dexcom G6 Continuous Glucose Monitoring System— 510(k) DEN170088
UnknownDexcom, Inc.
FDA 510(k) clearance DEN170088 for Dexcom G6 Continuous Glucose Monitoring System, Unknown on 2018-03-27. Applicant: Dexcom, Inc..
Clearance details
- Applicant
- Dexcom, Inc.
- Product code
- Code QBJ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- San Diego, CA, US
Adverse events under product code QBJ
product code QBJ- Death
- 180
- Injury
- 31,825
- Malfunction
- 1,792,244
- Other
- 36
- Total
- 1,824,285
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.